Agricultural pesticides

For licensing of pesticide importer-distributor the information required in Application Form No. FPA PRD FORM NO. P-150 (https://fpa.da.gov.ph/NW/images/FPAfiles/DATA/PesticideAppsForm/2020/Agr...) are the following: type of Application for Agricultural Pesticide Importer / Indentor / Exporter License (Conventional, Plant Incorporated Protectant (PIP), New, Renewal); Company information (Business Name of the Applicant, address, TIN number, Telephone number); Capitalization, Mechanism of the payment, type of activity, Pesticide imported (formulated, technical, name and address of the supplier); In country major warehouse point(s) (Name of warehouse/address, capacity); Form and package of imported material to be passed on to immediate recipient (as is, repacked, technical material, formulated products); Name of Accredited Responsible Care Officer (ARCO) attach photocopy of Accreditation ID (Name of ARCO, expiry date); Applicant's email address.

For the licensing of pesticide manufacturer/formulator/extruder, the information required in Application Form No. FPA PRD FORM NO. P-110
(https://fpa.da.gov.ph/NW/images/FPAfiles/DATA/PesticideAppsForm/2020/Agr...) are the following: type of Application for manufacturer/formulator/extruder (Conventional, Plant Incorporated Protectant (PIP), New, Renewal); Company information (Business Name of the Applicant, address, TIN number, Telephone number); Capitalization, Address of Formulation / Manufacturing / Extrusion Plant, Environmental Compliance Certificate No. / Permit to Operate No. / Expiry Date, List of Pesticides Formulated / Manufactured / Extruded (product, formulation type, product owner, volume/year); Formulation Capability Rated Capacity, No. of Employees, Area of Compound, Location of Plant, Occupational / Safety Arrangements, Technical Staff: Name, PRC License No., Plant Manager PRC license number, Formulation Chemist PRC license number, Quality Control Chemist PRC license number, Name and Address of Laboratory, Name of Accredited Responsible Care Officer (ARCO); Applicant's email address.

For the licensing of pesticide repacker, the information required in Application Form No. FPA FORM NO. P-120 (https://fpa.da.gov.ph/NW/images/FPAfiles/DATA/PesticideAppsForm/2020/Agr...) are the following: type of Application for repacker (Conventional, Plant Incorporated Protectant (PIP), New, Renewal); Company information (Business Name of the Applicant, address, TIN number, Telephone number); Capitalization, Address of Repacking Plant, Environmental Compliance Certificate No./Permit to Operate No./Expiry Date, Repacking Set-Up and Equipment, Rated Capacity, No. of Employees, List of Pesticides Products Repacked (product, repacking type, formulation type, importer/distributor); Information regarding the usage of brand name, In-charge of affixing or attaching the labels of repacked products (brand/label owner or repacker), Source of labels brand/label owner or repacker), Occupational/Safety Arrangements, Location of Plant, Area of Compound, Technical Staff: Name, PRC License No. (Plant Manager, , Quality Control Chemist) , Name of Accredited Responsible Care Officer (ARCO); Applicant's Email Address.

For pesticide product registration the data and information required in FPA FORM NO. P-022 for the product and FPA FORM NO. P-012 for active ingredient.
(https://fpa.da.gov.ph/NW/images/FPAfiles/DATA/PesticideAppsForm/2020/Reg...)
(https://fpa.da.gov.ph/NW/images/FPAfiles/DATA/PesticideAppsForm/2020/Reg...)

a) For the product, this shall include the following: Name and address of applicant, brand name, name of active ingredient and percent purity, formulation (% active ingredient and type); registration applied for: (new, new/tpa, renewal, resubmission); Use category (insecticide, herbicide, fungicide, others); name and address of manufacturer, name and address of formulator, packaging sizes, proposed use (crop/s, pest/s, A.I/HA [kg or Li], recommended dosage TBB/16Li[10CCT/BTS], product/ha[kg or li]); applicants representative (name, title, signature) and email address.

b) For the active ingredient, this shall include the following: Name and address of the applicant, active ingredient (common name and purity), chemical type, name and address of manufacturer, registration applied for (new, new/tpa, renewal, resubmission); proposed formulation(s) and composition (brand names of each); use category (insecticide, fungicide, herbicide and other); applicant’s representative (name, title, signature) and email address.

Application of Registration

Any person may file for registration of pesticide, which must be in the prescribed form addressed to the Authority and under oath, containing complete and detailed information.

Only local companies registered by the Securities and Exchange Commission to do business in the Philippines and duly licensed by the FPA may apply for registration of pesticide products. For purposes of these guidelines, a local company is a juridical person created under the Philippine law and licensed to do business in the country. Companies operating in the Philippines under PD 218 are excluded in this definition. Foreign suppliers or companies registered under the Securities and Exchange Commission as regional liaison offices (PD218) are not allowed to register products. For pesticides, the applicant or registrant should be the distributor or the local subsidiary of a foreign-based pesticide company.

A separate application shall be filed for each formulated product and active ingredient as well as for each source of the active ingredient.

For Experimental Use Permit (EUP)
Application form FPA Form No. P-002
(https://fpa.da.gov.ph/NW/images/FPAfiles/DATA/PesticideAppsForm/2020/EUP...)
shall include the following: Name and address of the applicant, product name, name of active ingredient & % purity, name and address of manufacturer of A.I, formulation % A.I. & type, use category (insecticide, herbicide, fungicide, others); crop(s) and target pest(s), total area covered by trial, total amount of A.I. equivalent/formulation needed, duration of trial, location of experiment, name of researcher, address of institution, applicants representative (name, title, signature, email address).

Table 2.2 of the FPA “Manual on Pesticide Regulatory Policies and Implementing Guidelines” provides the technical data requirements for issuance of the pesticide registration or EUP.

Tables

For CAIP requirements: Pesticide Circular No. 1, Series of 1981, the following are the lists of requirements for importation of pesticides:

1. The importer must be licensed by the FPA.
2. The pesticide product(s) and active ingredient(s) must bear a registration, or covered by the appropriate Experimental Use Permit (EUP).
3. The following must be specified in the request for importation:
i) Product, specifying % purity if technical material or active ingredient if formulated product
ii) Unit price
iii) Quantity
iv) Payment terms
v) Country of origin
vi) Destination
vii) Carrier/vessel
4. The pro-forma invoice must be attached. This shall enable the FPA to correlate the source of supply to the registration of the product.
5. The bill of lading, which verifies that the above transaction transpired at the term(s) and price(s) stated on the pro-forma invoice must be attached to the subsequent request for importation.
All unused Import Certificates must be returned to the FPA at the end of each quarter.

For licensing of pesticide importer-distributor Upon application for license, importers are required to submit/accomplish the following:

a) For New Applications:

1.Duly accomplished and notarized application form (original copy) with documentary stamps required.
2. For:
i) Corporation/Partnership - Copy of SEC Registration and Articles of incorporation
ii) Cooperative - Copy of CDA Registration.
iii) Single Proprietorship - Copy of Certificate of Registration of Business Name with DTI
3. Copy of latest Income Tax Return (ITR) and Financial Statements (FR).
4. Distributorship agreement/certification from the pesticide supplier/s.
5. Recommendation / Inspection Report from FPA Regional / Provincial Officer.
6. Registration of Pesticide Warehouse/s.
7. Photocopy of Accredited Responsible Care Officer (ARCO) ID.
8. Product Registration of pesticides to be sold. (Photocopy of Certificate of Product Registration (CPR) / Signed list of approved pesticide products).
9. Contract / Certification with the Manufacturer / Supplier.
10. Photocopy of Certificate of Attendance of one (1) symposium – Renewal ID.
11. Schedule of fees.

b) For renewal of license

1. Duly accomplished and notarized application form (original copy) with documentary stamps required.
2. For:
i) Corporation/Partnership - Copy of SEC Registration and Articles of incorporation
ii) Cooperative - Copy of CDA Registration.
iii) Single Proprietorship - Copy of Certificate of Registration of Business Name with DTI
3. Copy of latest Income Tax Return (ITR) and Financial Statements (FR).
4. Distributorship agreement/certification from the pesticide supplier/s.
5. Recommendation / Inspection Report from FPA Regional / Provincial Officer.
6. Registration of Pesticide Warehouse/s.
7. Photocopy of Accredited Responsible Care Officer (ARCO) ID.
8. Product Registration of pesticides to be sold. (Photocopy of Certificate of Product Registration (CPR) / Signed list of approved pesticide products).
9. Photocopy of Certificate of Attendance of one (1) symposium – Renewal ID.
10. Schedule of fees.

A license good for one year shall be issued upon approval of application.

For pesticide manufacturer/formulator/extruder and repacker

Requirements for the licensing of pesticide manufacturer / formulator / extruder and repacker

1. Duly accomplished and notarized application form (original copy) with documentary stamps.
2. For:
i) Corporation/Partnership - Copy of SEC Registration and Articles of incorporation
ii) Cooperative - Copy of CDA Registration.
iii) Single Proprietorship - Copy of Certificate of Registration of
Business Name with DTI
3. Copy of latest Income Tax Return (ITR) and Financial Statements (FS).
4. Copy of Environmental Compliance Certificate (ECC) and Permit to Operate (PTO) with DENR.
5. Production Process / Flow Chart.
6. Recommendation and Inspection Report from FPA Regional / Provincial Officer.
7. Written authority to repack / formulate / extrude / manufacture from the supplier.
8. Pre-licensing inspection report by the Pesticide Audit Team.
9. Registration of Pesticide Warehouse/s.
10. Photocopy of Accredited Responsible Care Officer (ARCO) ID.
11. Product registration of pesticide to be sold.
12. Compliance of FPA Manual on Occupational and Technical Safety of Pesticides manufacturing, formulation, repacking and extrusion plant.
i) Occupational Health and Safety Program (OHSP)
ii) Medical Health Examinations of Workers
13. Photocopy of Certificate of Attendance of one (1) symposium - Renewal ID.
14. Annual Capacity Output.
15. Schedule of fees

A license good for one year shall be issued upon approval of application.

For pesticide product registration

A complete application (submitted in duplicate) which consists of:

a) Form for registrant of an active ingredient (P-012) or registration of a Pesticide Product (P-022)
b) Complete data required to support the registration requested as specified in SECTION III of the Guidelines, particularly Table 2.2 on Data Requirements, with a certification that they comply with good scientific practice, GLP’s and test protocols.
c) A summary of the data submitted and an applicant’s assessment of how these data support registration for the purpose, uses and directions for use in the draft label.
d) Proof of registration in other countries where relevant.
e) Dummy label text.
f) A sample of the material to be registered must be submitted prior to registration unless the applicant presents convincing reason to the FPA as to why these should not be submitted at that time. The following must accompany an application: 1g analytical grade of the active ingredient(s). 10g technical material and 500ml or 0.500kg of the formulation.
g) Reviews of data done by other countries of international organizations, if available.
h) The appropriate fee.
i) Any authorization necessary to cite previously submitted data.

Data must be submitted in the standard 8 ½ x 14 paper, indexed and bound separately, i.e. one folder for each of the following sets of data: Specifications, Bioefficacy, Toxicology and Residues/ Environment Fate. The dummy label must appear as the first entry in each folder. Any additional data required must also be submitted as prescribed. Submission that does not follow these requirements shall not be accepted.

For Experimental Use Permit (EUP)

For experimental samples to be imported pesticide, an FPA-approved Experimental Use Permit (EUP) is required.
a) Accomplished application form
b) Technical data requirements
c) Application for a company license as Importer-National Distributor/End-user.

Table 2 of the FPA "Manual on Pesticide Regulatory Policies and Implementing Guidelines" provides the technical data requirements for issuance of the pesticide registration or EUP.

Table 2.2 Data Requirement Pesticide Products.pdf

The application for CAIP must be apply 60 days or earlier before the estimated time of arrival (ETA) of the imported product/technical material.

Applications may be filed on any working day of the year.