August 9, 1996

FPA MEMORANDUM CIRCULAR NO. 08-96

Pursuant to the provisions of IcDESA

I. Purpose

These updated guidelines provide information for the registration of the aforementioned products to ensure farmers and end-users that the products being marketed are of good quality as guaranteed by the manufacturers and/or distributors.

II. Coverage and Definition of Terms

These guidelines shall apply to new products filed for registration and those products having full or provisional registration status.

The following products are covered by the provisions of these guidelines:

A. Fertilizer

Any substance, solid or liquid, inorganic or organic, natural or synthetic, single or a combination of materials that is applied to the soil or on the plant to provide one or more of the essential elements to improve plant nutrition, growth yield or quality or for producing a chemical change in the soil which will contribute to the improvement of plant nutrition and growth.

1. Inorganic Fertilizer

Any fertilizer product the properties of which are determined predominantly by its content of mineral matter or synthetic chemical compounds. It also refers to any chemical compound which is in liquid or in solid form and contains considerable amounts of at least one of the essential plant nutrients, such as nitrogen, phosphorus, potassium, secondary macronutrients and the micronutrients.

a) Conventional grades shall include all inorganic fertilizers in solid or liquid forms which are highly soluble, proven effective for specified crops by field experiments for at least two years and which have full registration with FPA.

b) New grades shall include locally formulated or imported fertilizers with no previous registration with FPA.

c) Specialty grades shall include finished products recommended to overcome a specific problem or supply the nutrient need of a specific ornamental, indoor plant, lawn grasses or for any purpose other than growing agricultural food, feed, fiber or other industrial crops.

2. Organic Fertilizer

Any product of plant and/or animal origin that has undergone decomposition through biological, chemical and/or any other process as long as the original materials are no longer recognizable, free from plant or animal pathogens, soil-like in texture, contains not less than 20% organic matter (o.m.) oven-dry basis and can supply nutrients to plants. All other materials that fall short of these requirements shall be classified as soil conditioners or amendments whichever is applicable.

a) Pure Organic decomposed plant or animal materials to which decomposing activators may have been added to hasten the process of decomposition and to which no chemical or inorganic fertilizer material has been added to the finished product to affect the nutrient content.

b) Fortified/Enriched Organic Fertilizer an organic fertilizer material which had been enriched with microbial inoculants, hormones and/or chemical additives to increase its nutrient content. cSHATC

B. Soil Conditioner/Soil Amendment

Any organic or inorganic material, natural or synthetic, that is applied to the soil to modify certain soil physical properties, such as structure, moisture retaining capacity, shrinking and swelling capacity or resistivity to crusting and to improve soil chemical and biological conditions. Examples are polyelectrolytes such as complex vinyl and acrylic, gypsum, diatomaccous earth, vermiculite, perlite, lime, and sawdust. Strictly, a fertilizer is also an amendment but the term is more commonly used for materials applied for their fertilizing value.

C. Raw Materials

Any organic or inorganic material used in the production of intermediate or finished fertilizer products. This also includes naturally-occurring fertilizers such as guano, rock phosphate, limestone, dolomite, peat, gypsum and sulfur deposits that are found in nature, mined and used in fertilizer production.

D. Plant Growth Regulator (Promoter)

Any organic or inorganic compound, natural or synthetic, which in low concentration promotes or modifies any physiological process in plants.

E. Microbial Inoculants

Biologically active products containing optimum population of one or a combination of active strains of bacteria, actinomycetes, algae and fungi that are useful in different biological activities, such as N-fixation, decomposition of organic residues and solubilization/concentration of a specific element from the soil.

III. Process of Registration

A. Requirement for Product Registration

1. Administrative Requirements

a. Duly accomplished and notarized application form.

b. FPA license to manufacture/import/distribute/etc.

2. Technical Requirements (See Summary in Attachment 1)

a. Inorganic Fertilizer

a.1. Conventional inorganic fertilizer material including specialty fertilizers

a.1.1. For New Application

1) Sample of the finished product for confirmatory analysis at any FPA accredited laboratory

2) Proposed label or bag

3) Certificate of Analysis from the source/country of origin

4) Brochure/pamphlets of exporting/manufacturing firm (company profile)

a.1.2. Renewal Application

1) Inform FPA of any changes on the above items

2) Recent chemical analysis from an FPA accredited laboratory

a.2. New inorganic fertilizer including specialty fertilizer

a.2.1. For New Application

1) Proposed label or bag

2) Guaranteed Analysis of Nutrients or Active Ingredients

A certificate of analysis of nutrients by an FPA accredited laboratory must be submitted to FPA by the applicant together with two product samples taken from the same batch for confirmatory analysis at any FPA accredited laboratory. Costs of such analysis shall be on the applicant's account.

3) Source, kind and analysis of raw materials

4) General description of production process

5) Brochure

6) Field test report of an FPA accredited researcher in accordance with FPA Test Protocol (Attachment II)

7) Performance evaluation of efficacy from country of origin (if imported)

8) Local inspection report by FPA staff on plant sites, raw materials, production process, laboratory facilities and manpower, sanitation, occupational health hazard and environmental pollution (local)

a.2.2. Renewal

1) Inform FPA of any changes on the above items

2) Recent chemical analysis from an FPA accredited laboratory

b. Organic Fertilizers

b.1. New Applications

1) Proposed packaging materials

2) Guaranteed Analysis of Nutrient or Active Ingredients

A certificate of analysis of nutrients by an FPA accredited laboratory must be submitted to FPA by the applicant together with two product samples taken from the same batch for confirmatory analysis at any FPA accredited laboratory. Costs of such analysis shall be on the applicant's account.

Example:

Total Nitrogen (%)

Ammoniacal nitrogen (%)

Nitrate nitrogen (%)

Organic nitrogen (%)

Total P₂O₅ (%)

Available P₂O₅ (%)

Total K₂O (%)

Water Soluble K₂O (%)

For Classification, the following Specifications are as follows:

3) Kind and analysis of raw materials

4) General description of production process

5) Brochure

6) Field test report of an FPA Test Protocols (Attachment II)

7) Performance evaluation of efficacy from country of origin (if imported)

8) Local inspection report by FPA staff on plant site, raw materials, production process, laboratory facilities, manpower, sanitation, health hazard and environmental pollution.

9) Any claim on the presence of beneficial microorganism shall be specified and quantified.

10) Test for Pathogens

b.1.2^* Renewal

1) Inform FPA of any changes on the above items

2) Recent chemical analysis from an FPA accredited

c. Soil Conditioners and Soil Amendments

c.1. New Application

1) Proposed packaging material

2) Guaranteed Analysis of Nutrients or Active Ingredients

A certificate of analysis of nutrients by an FPA accredited laboratory must be submitted to FPA by the applicant together with two product samples taken from the same batch for confirmatory analysis at any FPA accredited laboratory. Costs of such analysis shall be on the applicant's account. cTESIa

3) Source, kind and analysis of raw materials

4) General description of production process

5) Brochure

6) Field test report of an FPA accredited researcher in accordance with FPA Test Protocols (Attachment II)

7) Performance evaluation of efficacy from country of origin (if imported)

8) Local inspection report by FPA staff on plant site, raw material, production process, laboratory facilities and manpower, sanitation and hazards to health and environment (local product)

9) Additional Information for Lime as Amendment

a) % particle size passing through 60, 40, 20 and 10 mesh sieve

b) Percent active compound

CaCO₃%

MgCO₃

c) Neutralizing value (CaCO₃ equivalent, %)

c.2 Renewal

1) Inform FPA of any changes on the above items

2) Recent chemical analysis from an FPA accredited laboratory

d. Plant Growth Regulatory (Promoter)

d.1. New Application

1) Proposed label

2) Guaranteed Analysis of Nutrients or Active Ingredients

A certificate of analysis of nutrients by a reputable laboratory (independent local or foreign analytical laboratory) must be submitted to FPA by the applicant together with the product sample for confirmatory analysis at any FPA accredited laboratory.

3) Product Physical and Chemical Properties

a) Chemical composition of the technical (raw material) and commercial product, state impurities and inert ingredients.

b) Chemical name of the active ingredients

c) Chemical structure

d) Flammability

e) Volatility

f) Stability

4) Toxicological Requirements (for synthetic plant growth regulator)

Acute Oral Toxicities

Acute Dermal Toxicities

5) General description of production process

6) Brochure

7) Field test report of an FPA-accredited researcher in accordance with FPA Test Protocols (Attachment II)

8) Performance evaluation of efficacy from the country of origin

9) Local inspection report by FPA staff on plant site, laboratory facilities, manpower, sanitation and hazards to health and environment (local product)

d.2 Renewal

1) Inform FPA of any changes on the above items

2) Recent chemical analysis from an FPA accredited laboratory

e. Raw Materials

e.1 New Application

1) Proposed packaging material

2) Guaranteed analysis of nutrient content and active substances

A certificate of analysis of nutrients by an FPA accredited laboratory must be submitted to FPA by the applicant together with two product samples taken from the same batch for confirmatory analysis at any FPA accredited laboratory. Costs of such analysis shall be on the applicant's account.

e.2 Renewal

1) Inform FPA of any changes in the above item

2) Recent chemical analysis from an FPA accredited laboratory

f. Microbial Inoculant

f.1 New Application

1) Proposed label

2) A certificate of analysis of the population of one or a combination of active strains of bacteria, actinomycetes, algae and fungi by an accredited laboratory together with two product samples taken from the same batch for confirmatory analysis at any FPA accredited laboratory. Costs of such analysis shall be on the applicant's account.

3) Field test report of an FPA accredited researcher in accordance with FPA Test Protocols (Attachment II)

4) Brochure

5) Local inspection report by FPA staff on plant site, raw material, production process, laboratory facilities and manpower, sanitation, health hazard and environment. (local product)

6) Test of Pathogens

f.2 Renewal

1) Inform FPA for any changes on the above items

2) Recent chemical analysis from an FPA accredited laboratory

B. Guaranteed Analysis

The composition of the fertilizer material with respect to its minimum plant food nutrient contents shall conform with the guaranteed analysis and which shall be indicated on the proposed label of the package. The permissible minimum deviation from the guaranteed nutrient analysis shall be plus or minus two percent of the declared percentage content of each of the major nutrients but for organic fertilizers, the allowable deviation shall be plus or minus five percent.

A certificate of analysis of nutrients by an FPA accredited laboratory must be submitted to FPA by the applicant together with two product samples taken from the same batch for confirmatory analysis at any FPA accredited laboratory. Costs of such analysis shall be on the applicant's account.

C. Biological Efficacy Data Generation

1. General Information

1) Bioefficacy data provide a mechanism to ensure that the fertilizer product will perform as indicated in the label.

2) Adequate data to support claims on the label on the effectiveness of a fertilizer to supply the nutrients guaranteed by the product and needed by the plant should be provided by the registrant as an integral part of registration. AHcCDI

3) Two-season testing showing consistent positive results for a target crop in one or different regions are acceptable for full registration for crops in the same commodity grouping.

4) For the product to qualify for provisional registration, one season testing in one region is acceptable. However, provisional registration shall be limited only to the test crop and other similar crops belonging to the same crop group.

2. Experimental Use Permit (EUP)

Experimental Use Permit (EUP) should be applied for and approved before any bioefficacy field test is conducted to generate data required for registration (Attachment III) as the data must ultimately meet the requirements for registration. EUP applicants should take necessary measures to ensure that the test meets the standard protocols for efficacy testing. Studies which are conducted without approved EUP and not in accordance to FPA standard protocols will have to be repeated and that will cause additional cost to the registrant and delay in the registration of the product.

All experiments should be conducted by FPA accredited researchers. FPA accredited researchers belonging to a private firm are not allowed to conduct efficacy trial for their company.

The applicant must submit the application for EUP at least one month prior to the conduct of the test. A return receipt will serve as the approval for the EUP. Whenever the application is disapproved by FPA, a written notice will be sent to applicant within 15 days after the application.

Conditions such as limiting the quantity of importations of the product may be imposed for those applying for EUP. The volume of product to be imported shall be limited to the amount needed for the generation of efficacy data. Likewise for locally produced product, the amount to be processed shall be limited to the amount needed for the generation of data which FPA requires.

Specific information and conditions are stated in Attachment III.

An EUP is valid only for one growing season of testing a crop. The period of coverage for an EUP may be extended upon request and payment of additional filing fee provided the reasons are acceptable to the Authority. Extension for EUP shall be under a specified period of time.

3. Test Protocol

Efficacy data generation should comply with the basic requirements specified in the efficacy test protocol and should be conducted by FPA accredited researcher. (Attachment III)

4. Expansion of uses which include crop groupings

FPA prescribed test protocols for specific crops per product type are contained in Attachment II. Crop groupings on the representative crop are contained in Attachment IV.

For the expansion of the product's use, one efficacy test with significant results should be conducted on the target crop. Other crops belonging to the same crop grouping do not need an additional efficacy test.

D. Labeling Requirement

The label is very important in packaging and marketing a fertilizer product. It is a legal document. Information on the label provides the sellers and the buyers with the safe and effective use of the product for which it is registered. Fertilizer Circular 83-06, series of 1983 defines the label requirements for liquid and specialty fertilizers.

"Label" means a display of the written, printed or graphic information on the immediate container of any fertilizer product. Label must be of such design and material that does not deteriorate easily, become illegible or get separated from the container under the rigors of transport, storage and use. It should withstand extreme weather conditions.

General Considerations in Labeling (Liquid/Specialty fertilizer)

1. All information contained in the label must be legible, in English and/or Filipino.

2. Label must have purple border band of a minimum of 1/8 inch for container smaller than 250 ml or 300 grams net weight and 1/4 inch for bigger container up to 4 liter or 5 kilograms.

3. For products packed in cardboard boxes or plastic bags weighing 1-5 kilograms, the items required on product information and direction for use should be printed directly on the container. The required border band should also be printed.

4. For products sold in containers smaller than 250 ml, only the product information is required to be printed on the label. These should be printed in the space specified in the same label. The direction for use should be printed in a separate leaflet or flier.

Specific Considerations in Labeling (liquid foliar and specialty fertilizer)

The label must contain the following:

Middle Panel:

Trade Name/Fertilizer Grade

Total N (%)

Ammoniacal nitrogen (%)

Nitrate nitrogen (%)

Total P₂O₅ (%)

Available P₂O₅ (%)

Water Soluble K₂O (%)

Trace Elements (ppm of each element, if any)

Artwork (only crops registered)

Net Weight/Volume of Content

Caution

F.P.A. Registration No.:

KEEP OUT OF REACH OF CHILDREN

Right Panel:

Directions for Use: Crops: dosage: frequency

Other instructions/information

Left Panel:

Manufacturer/Distributor, Name and Address

Compatibility

Warranty

Package Storage and Disposal

Date of Formulations; Lot No.

Color Band Purple

Specific Considerations in Marking of Bags of Solid Fertilizers

The bag or container shall be marked with the following:

Front:

Brand Name

Guaranteed Analysis

Total N (%)

Ammoniacal nitrogen (%)

nitrate nitrogen (%)

Total P₂O₅ (%)

Available P₂O₅ (%)

Total K₂O (%)

Water Soluble K₂O (%)

Trace Elements (ppm of each element, if any)

Moisture Content

O.M. %

C: N

F.P.A. Registration Number

Back:

Name of Manufacturer

Address of Manufacturer

Batch number and coded months and year of Manufacture

Contents (net mass, in kg.)

E. Review Process

Application for registration should be duly accomplished and submitted in duplicate.

It will be screened for completeness and if found incomplete, it will be returned to applicant. Filing fee will be collected when all the required documents are submitted. The application will be entered into the registration tracking system and the data forwarded to Technical Consultants. caSDCA

Reviewers/Technical Consultants will be expected to complete the review of the data within 30 days. If the results of reviews are satisfactory, the FPA will notify the applicant of the status of registration.

IV. Types of Registration Granted

The types of registration granted are as follows:

1. Provisional/Conditional Registration the technical requirements had been completed including one season of significant efficacy test on a representative crop.

2. Full Registration granted when all the technical requirements were satisfactorily complied with including another season efficacy test on a representative crop.

V. Other Provisions

A. Validity and Renewal of Registration

Full registration of a product shall be effective for 3 years and shall expire on December 31 of the third year.

A provisional registration shall expire on December 31 of the same year from date of issue.

Renewal of full or provisional registration may be filed until March 31 of the subsequent year after expiration after which surcharges equivalent to 100% of the registration fee will be levied. No renewal applications will be accepted after June 30 of that year. Failure to renew registration will mean automatic cancellation of the product registration. Products previously registered but registration of which was cancelled due to failure to renew on time will be treated as new application.

B. Upgrading of Provisional Registration to Full Registration

A provisional registration will be upgraded to a full registration when all the technical requirements including the second season of significant efficacy test on the same representative target crop have been met satisfactorily.

A provisional registered product shall be renewed only once hence applicant should generate immediately the required bioefficacy data for full registration status.

C. Label Expansion

Product label should contain only recommendations for crops in particular group on which the product had been found to be effective. For label expansion, one efficacy test with significant result should be conducted on the representative crop in the desired crop grouping. Other crops belonging to the same crop grouping do not need an additional efficacy test. (See Attachment IV-Crop Groupings)

D. Protection of Data

Data submitted to support the first full or provisional registration will be granted protection for a period of five years from the date of first issuance of registration. During this period subsequent registrants may rely on these data only with first party authorization or otherwise must submit their own data. After five years from the date of first issuance of registration, all data may be freely cited in support of registration by any applicant, provided convincing proof is submitted that the product being registered has the same raw materials and production process.

E. Transfer of Registration

Transfer of registration is accepted provided that the product to be transferred is currently registered and the following requirements are satisfactorily complied with:

1) Application form duly accomplished and notarized

2) Deed of Transfer

3) Propose Label

4) Certificate of chemical analysis by an FPA accredited laboratory

5) Sample for confirmatory analysis

F. Registration of Product on a per Supplier Basis

Any product being applied for registration should be registered on a per supplier basis regardless of country of origin.

VI. Payment of Fees

The Fee for an Experimental Use Permit (EUP) is P500.00 for local product and P1,000.00 for imported ones. EUP payment is on a per product per crop per cropping period.

Registration fees shall be collected per product based on FPA approved rates for new and renewal application.

VII. Repealing Clause

All previous guidelines and circulars inconsistent herewith are hereby superceded or modified accordingly.

VIII. Administrative Penalties

Administrative sanctions shall be imposed against all persons or entities who shall violate or shall refuse to abide by the provisions of this Memo Circular. These sanctions shall include, but will not be limited to, the cancellation of registration, revocation of license, refusal to endorse an application for the availment of the deferred tax payment scheme and such other sanctions that the FPA is empowered to do under its charter. The imposition of administrative sanctions shall be without prejudice to the filing of criminal case against the erring persons pursuant to the penalty clause of

VIII. Effectivity

This Guideline shall be effective thirty (30) days from the date of issuance.

FRANCISCO C. CORNEJO
Administrator

ATTACHMENT

I HEREBY CERTIFY that the foregoing data and information including those in the annexes hereof are true and correct to the best of my knowledge.

IN WITNESS WHEREOF, I have hereunto set my hands this _____ day of _________________________, 19 ____ at _________________________ Philippines.

_______________________________

Name & Signature of Firm's President
Manager or Authorized Representative

REPUBLIC OF THE PHILIPPINES
PROVINCE OF _______________
MUNICIPALITY OF ___________

SUBSCRIBED AND SWORN TO before me this ____________ day of _________________ 19 _______ at ___________________, Philippines. Affiant exhibited to me his/her Residence Certificate No. __________________ Issued on ________ 19 _________ at __________________ Philippines.

__________________________

NOTARY

Until December 31, 19 _______

PTR No. __________________

Doc. No. __________

Book No. __________

Page No. __________

Series of 19 ________

Original should bear P15.00 documentary stamps.

FPA-Form PR-I Annex

INFORMATION SHEET ON COST COMPONENTS AND PRICES

(For Imported Products) THacES

To be based on most recent importation

Note: Enumerate warehouse & corresponding ex-warehouse prices if more than one.

Application No.: ___________________

FPA-Form PR-L Official Receipt No.: ________________

Amount Paid: _____________________

Place: ___________________________

Application for Locally Manufactured/Mined Fertilizer Product Registration

1. a. Brand/Trade Name: _________________________________________

b. Type of Product: ___________________________________________

c. Certified/Guaranteed Analysis of Product: ________________________

________________________________________________________

2. a. Name of Producer/Company: _________________________________

b. Business Address/es & Tel. Nos.: ______________________________

1) Head Office: _______________________________________________

_____________________________ Tel. Nos. _____________

2) Regional/Provincial Office: ____________________________________

_____________________________ Tel. Nos. _____________

3) Location of Plant: ___________________________________________

_____________________________ Tel. Nos. _____________

4) Location of Warehouses: ______________________________________

_________________________________________________________

3. List of Materials/Raw Materials used in the Production of Product: ___________

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

4. Actual Production Process (for original application):

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

5. Target Users/Crops: ______________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

6. Agency Handling Experimental/Field Test (if any): ________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

I HEREBY CERTIFY that the foregoing data and information including those in the annexes hereof are true and correct to the best of my knowledge.

I WITNESS WHEREOF, I have hereunto set my hands this _________ day of _____________, 19 _______ at ______________________.

_______________________________________

Name and Signature of firms President, Manager of Authorized Representative

REPUBLIC OF THE PHILIPPINES
PROVINCE OF ________________
MUNICIPALITY OF ____________

SUBSCRIBED AND SWORN TO before me this ____ day of ____________, 19___ at _______________, Philippines. Affiant exhibited to me his/her Residence Certificate No. __________________ issued on _____________ 19____ at _____________, Philippines.

__________________________

NOTARY

Until December 31, 19 _______

PTR No. __________________

Doc. No. ___________

Book No. __________

Page No. __________

Series of 19 ________

Original should bear P15.00 documentary stamps.