Form PPCR1
Application for introduction of bio-fertilizers (R.12 (1))
Information for applicants
1. The applicant is responsible for the information submitted.
2. The application shall be submitted in 4 hard copies, separately bound.
3. All parts shall be filled by summarising the required information in the spaces
provided and referenced to clearly labelled annexes.
4. A cover letter addressed to the Secretariat (Managing Director KEPHIS) shall
accompany this application form.
5. In case of more than one product, the applicant shall fill a separate form for each
product.
6. All confidential business information shall be submitted in a separate and sealed file
and clearly marked as `CBI`.
7. An applicant who is not a resident in Kenya shall appoint an authorised local agent
permanently residing in Kenya. An original letter of appointment must accompany
this application.
8. Additional information relating to the application shall be provided if required.
9. The use of genetically modified organisms (GMOs) shall be cleared by the National
Biosafety Authority before an application is made.
PART A: GENERAL INFORMATION
1. Name of applicant (full name of the legal entity making
the application)
2. Address of the applicant/company
(*Physical location, *Postal address, *Telephone, *Cell
phone, *Email, website) *All must be provided
3. Name of Local agent (if different from applicant)
4. Address of the local agent where applicable
(*Physical location, *Postal address, *Telephone, *Cell
phone, *Email, website) *All must be provided
5. Name of Manufacturer
6. Address of the Manufacturer
(*Physical location, *Postal address, *Telephone, *Cell
phone, *Email, website) *All must be provided
7. Purpose of introduction/multiplication (Tick where
appropriate):
a) Research
b) Commercial
c) Personal use
d) Other (Specify)_____________
8. Intended use (Tick where appropriate):
a) Veterinary
b) Public health
c) Industrial
d) Agriculture
e) Forestry
f) Environment
g) Other (specify)
9. Quantity of trial sample to be imported
PART B:DETAILS OF THE ORGANISM
1. The scientific name (s) of the organism (Genus, species,
strain/variety) All must be provided.
2. Common Name
3. The type of organism/micro-organism (Tick where appropriate)
a) Bacteria
b) Protozoa
c) Virus
d) Fungus
e) Nematode
f) Other (Specify)________
4. Are the organisms live or deactivated? If deactivated describe the
process used (Attach evidence)
5. Biology of the organism (attach annexes including peer reviewed
publications)
6. Hyper-parasites, contaminants, pests or likely pests to be associated
with the organism (Detailed descriptions; attach analysis and quality
control reports)
7. Mode of dispersal/ spread of the organism
8. Mode of action of the organism
9. Origin of organism and world distribution
10. Natural occurrence (Ecosystem where it is found naturally)
11. Target plant species and environment
12. Information on efficacy of the organism
13. Description of any negative effects caused by the organism
14. Stability of the organism in the environment
15. Environmental requirements of the organism
16. Effect of the organism on availability of soil nutrients and water
17. Impact of the organism in its area of distribution
18. List of countries where the organism is approved for use (attach
evidence)
PART C: IDENTITY AND INFORMATION OF FORMULATED PRODUCTS
1. Trade/commercial name
2. Purpose of introduction (Tick where appropriate)
a) Research
b) Commercial
c) Personal use
d) Other (specify)
3. Details of Formulator (*Physical location, *Postal
address, *Telephone, *Cell phone, *Email, website)
*All must be provided
4. Details of trademark owner (Names, Postal address,
Physical address)
5. Origin of the Product (country and state/district)
6. Product function (e.g. nitrogen fixing, phosphate
solubilizing etc.)
7. Intended use: (Tick appropriately)
a) Agriculture
b) Forestry
c) Veterinary
b) Public health
c) Industrial
f) Other (Specify)
8. Formulation Details
8.1 Physical state of formulation: (solid, liquid, etc.)
8.2 Type of formulation (EC, WP, SC etc.)
8.2 Declare full composition of formulation(s) (active organisms) (Information may be
attached in a sealed envelope)
Active organism(s): Minimum count of active organism
(Common name/s)
8.3 Identification of contaminants Maximum count of contaminants
(CFU)
9. Is the product registered in the country of Yes
origin? No If no give reasons
10. Is the product registered in other countries? Yes
No
State the countries
11. Certificate of analysis from the country of Available
origin Not available
12. Specify physical characteristics of the
product
13. Production
13.1. Describe the production method
13.2. Provide the quality control procedures applied in the production
and check for contaminants (Attach quality control procedures and
reports)
14. Shelf life (attach reports)
15. Market label for the country of manufacture (Attach as an annex)
16. Information on product use
16.1. Mode of application
16.2. Area of application
a) Green house
b) Open field
c) Other (Specify)
16.3. Dosage rates and frequency of application
17. Mode of action (Attach supporting scientific publications)
18. Description of benefits (Attach supporting scientific publications)
19. Effect on availability of soil nutrients and water
20. Environmental requirements (Attach supporting scientific publications)
21. Information on tank mixing (combined use/compatibility) (attach
reports)
22. Information on efficacy of the product
23. Packaging
23.1. Type of Packaging material / container
23.2. Pack size (s)
23.3. Describe the disposal of packaging material
24. Describe decontamination procedures
25. The proposed final disposition of the product (e.g. incineration,
burying, treatment etc)
PART D. SAFETY INFORMATION
1. Toxicology (Formulated product)
a. Rat Acute Oral Acute Dermal Inhalation LC
(LD 50 (LD50 mg/kg) 50
mg/kg) (mg/l/hour)
Experimental Experimental Experimental
Calculated Calculated Calculated
b. Rabbit (tick Skin irritation Eye irritation
appropriately) None Mild Moderate Severe
c. Skin None Mild Moderate Severe
Sensitization in
guinea pig (tick
appropriately)
d. Summary of other mammalian toxicological studies: e.g. livestock, wildlife, poultry,
pets
2. Material Safety data (Attach MSDS)
3. Summary of Eco toxicological Attach evidence or copy of studies
effects
1.6.1 Toxicity to bees
1.6.2 Toxicity to fish and other aquatic organisms
1.6.3 Toxicity to birds
1.6.4 Toxicity to earthworms
1.6.5 Toxicity to soil micro-organisms
1.6.6 Toxicity to other non-target organisms
1.6.7 Toxicity to other non-target plants
1.6.8 Fate in the environment (persistent, biodegradable)
Metabolites and their identity
1.6.9 Other effects: Specify
Any additional information that will be useful to support the evaluation
process will be accepted.
PART F: DECLARATION
For and on behalf of........................................
I hereby certify that the above mentioned information and data provided in support of
this application are to the best of my knowledge true, correct and complete.
…………………………………
Name in full (Printed)
……..…………………………… ….……………………...........................................
Official Title Signed : Date:
FOR OFFICIAL USE
Official Stamp Remarks
of Applicant / Company ….……………………...........................................
Signed : Date:
Guidelines for application for introduction of bio-fertilizers
PART A: GENERAL INFORMATION
1. Name of applicant Indicate name of the person/ company
making the application.
2. Address of the applicant/company Indicate address of the person/company
(*Physical location, *Postal address, making the application including;
*Telephone, *Cell phone, *Email, *Physical location, *Postal address,
website) *All must be provided *Telephone, *Cell phone, *Email,
website
All that have (*) must be provided.
3. Name of Local agent Indicate the full name of the local agent.
Where the applicant is not a resident in
Kenya
4. Address of the local agent where Indicate address of the local agent
applicable including; *Physical location, *Postal
(*Physical location, *Postal address, address, *Telephone, *Cell phone,
*Telephone, *Cell phone, *Email, *Email, website
website) *All must be provided All that have (*) must be provided.
5. Name of Manufacturer Indicate name of the manufacturer
6. Address of the Manufacturer Indicate address of the manufacturer
(*Country, *Physical location, *Postal including; *Country, *Physical location,
address, *Telephone, *Cell phone, *Postal address, *Telephone, *Cell
*Email, website) *All must be provided phone, *Email, website
All that have (*) must be provided.
7. Purpose of introduction/multiplication Indicate the reason for introduction of
(Tick where appropriate): the product by selecting from the options
a) Research given
b) Commercial
c) Personal use
d) Other (Specify)_____________
8. Intended use (Tick where Indicate the area of intended use by
appropriate): selecting from the options given
a) Veterinary
b) Public health
c) Industrial
d) Agriculture
e) Forestry
f) Environment
g) Other (specify)
9. Quantity of trial sample to be Indicate the desired quantity of the
imported product to be imported
PART B:DETAILS OF THE ORGANISM
1. The scientific name (s) of the organism Give full scientific name of the
(Genus, species, strain/variety) All organism including any changes in
must be provided. naming in the recent past.
2. Common Name Indicate where possible, the
common name
3. The type of organism/micro-organism Tick the appropriate type of
(Tick where appropriate) organism
a) Bacteria
b) Protozoa
c) Virus
d) Fungus
e) Nematode
f) Other (Specify)________
4. Are the organisms live or deactivated? Give information on deactivated
If deactivated describe the process organisms
used (Attach evidence) Attach evidence of deactivation
process or production (deactivation
certificate/flow chart or any other
available document
5. Biology of the organism (attach Give information on life cycle,
annexes including peer reviewed reproduction, parasitism,
publications) competition, virulence etc.
6. Hyper-parasites, contaminants, pests Give detailed descriptions; attach
or likely pests to be associated with the analysis and quality control reports
organism (Detailed descriptions; attach
analysis and quality control reports)
7. Mode of dispersal/ spread of the Give information on the behaviour of
organism the organism under typical
environmental condition
8. Mode of action of the organism Describe how the product works.
Principal mode of action should be
indicated.
Give information on site of action
and mode of entry in the target.
State whether there are any
metabolites involved.
9. Origin of organism and world Give the geographical region and the
distribution place in the ecosystem from where
the organism was isolated. Give the
method of isolation and indicate
whether the organism is Generally
Regarded as Safe (GRAS).
10. Natural occurrence (Ecosystem where Give information on the specific
it is found naturally) ecosystem where the organism is
found.
11. Target plant species and environment Give any available information on
the plant species and the
environment in which the plant
species is grown
12. Information on efficacy of the organism Give reports on uses and
performance of the organism.
13. Description of any negative effects Provide available information on the
caused by the organism effects of the organism on non-
target organism within the area in
which it would be spread and the
occurrence of non-target organisms
that are closely related to the target
species.
14. Stability of the organism in the Provide any information on possible
environment mutation traits and uptake of
exogenous genetic materials and the
environmental conditions of the
proposed use.
15. Environmental requirements of the Give the conditions required for the
organism optimum establishment of the
organism (e.g. pH, Temperature,
humidity, UV)
16. Effect of the organism on availability of Give information on the interaction
soil nutrients and water of the organism with the soil Macro
and micro nutrients with water.
17. Impact of the organism in its area of Give information on the negative and
distribution positive effects of the organism in its
area of distribution.
18. List of countries where the organism is Provide evidence of approval or
approved for use (attach evidence) evidence for exemption for approval
for registration
PART C: IDENTITY AND INFORMATION OF FORMULATED PRODUCTS
1. Trade/commercial name Specify
2. Purpose of introduction (Tick where Indicate the reason for introduction
appropriate)
a) Research
b) Commercial
c) Personal use
d) Other (specify)
3. Details of Formulator (*Physical Give information on Physical location,
location, *Postal address, *Telephone, Postal address, Telephone, Cell phone,
*Cell phone, *Email, website) *All Email, website
must be provided
4. Details of trademark owner (Names, Give information on Physical location,
Postal address, Physical address) Postal address, Telephone, Cell phone,
Email, website
5. Origin of the Product (country and Specify the origin of the product
state/district)
6. Product function (e.g. nitrogen fixing, Specify product function
phosphate solubilizing etc.)
7. Intended use: (Tick appropriately) Tick appropriately
d) Agriculture
e) Forestry
f) Veterinary
b) Public health
c) Industrial
f) Other (Specify)
8. Formulation Details
8.1 Physical state of formulation: (solid, liquid, etc.) Must be provided
8.2 Type of formulation (EC, WP, SC etc.)
8.2 Declare full composition of formulation(s) (active organisms) (Information may be
attached in a sealed envelope)
Active organism(s): Minimum count of active organism
(Common name/s) (Give details)
8.3 Identification of contaminants Maximum count of contaminants
(CFU)
(Give details)
8.4.1 Is the product registered in the country of Yes
origin? No If no give reasons (Tick
appropriately)
8.4.2 Is the product registered in other Yes
countries? No
State the countries (Tick
appropritely)
8.5 Certificate of analysis from the country of Available
origin Not available
(Tick appropriately)
8.6 Specify physical and chemical Give the physical and chemical
characteristics of the product properties of the product.
9. Production
9.1 Describe the production method Describe the method
9.2 Provide the quality control procedures
applied in the production and check for
contaminants (Attach quality control procedures
and reports)
9.3 Shelf life (attach reports)
9.4 Market label for the country of manufacture
(Attach as an annex)
10. Information on product use
10.1. Mode of application Specify the application method
10.2. Area of application Specify the area where the product
a) Green house will be used
b) Open field
c) Other (Specify)
10.3. Dosage rates and frequency of application Specify the recommended
application rates and the frequency
of application.
11. Mode of action (Attach supporting scientific Describe how the product works.
publications) Principal mode of action should be
indicated.
Give information on site of action
and mode of entry in the target.
State whether there are any
metabolites involved.
12. Description of benefits (Attach supporting Give information on positive impacts
scientific publications) of the product
13. Effect on availability of soil nutrients and Give information on the interaction
water of the product with the soil Macro
and Micro nutrients with water.
14. Environmental requirements (Attach Provide information on the optimal
supporting scientific publications) conditions for the organism
15. Information on tank mixing (combined Give details
use/compatibility) (attach reports)
16. Information on efficacy of the product .
17. Packaging
17.1 Type of Packaging material / container Give the type of the container used
in packaging the product
17.2 Pack size (s) Give details on the intended pack
sizes
17.3 Describe the disposal of packaging material Give details on the disposal
procedures of the packaging material
18. Describe decontamination procedures Give details
[Link] proposed final disposition of the product Give details
(e.g. incineration, burying, treatment etc)
PART D. SAFETY INFORMATION
4. TOXICOLOGY (Formulated product) (Provide)
1.1 Rat Acute Oral Acute Dermal Inhalation LC
(LD 50 (LD50 mg/kg) 50
mg/kg) (mg/l/hour)
Experimental Experimental Experimental
Calculated Calculated Calculated
1.2 Rabbit (tick Skin irritation
appropriately) None Mild Moderate Severe
Eye irritation
None Mild Moderate Severe
1.3 Skin Sensitization None Mild Moderate Severe
in guinea pig (tick
appropriately)
1.5 Summary of other mammalian toxicological studies: e.g. livestock, wildlife, poultry,
pets
Material Safety data (Attach MSDS)
1.6 Summary of Eco toxicological effects
1.6.1 Toxicity to bees Provide information
1.6.2 Toxicity to fish and other aquatic organisms Provide information
1.6.3 Toxicity to birds Provide information
1.6.4 Toxicity to earthworms Provide information
1.6.5 Toxicity to soil micro-organisms Provide information
1.6.6 Toxicity to other non-target organisms Provide information
1.6.7 Toxicity to other non-target plants Provide information
1.6.8 Fate in the environment (persistent, Provide information
biodegradable)
1.6.9 Metabolites and their identity Provide information
1.6.9 Other effects: Specify Provide information
