Published: 2003-08-08
Key Benefits:
INDEX TO SUBSIDIARY LEGISLATION
Agrochemicals Regulations
(under section 31)
(8th August, 2003)
ARRANGEMENT OF REGULATIONS
REGULATION
1. Citation
2. Interpretation
3. Application to register an agrochemical
4. Registration
5. Other applications
6. Labelling
7. Duty of licensee
8. Promotion and advertisement
9. Record keeping by licensee
10. Storage
11. Safe handling
12. Disposal of waste
13. Training course
14. Offence and penalty
First Schedule
Second Schedule
Third Schedule
Fourth Schedule
Fifth Schedule
S.I. 37, 2003,
S.I. 36, 2005.
These Regulations may be cited as the Agrochemicals Regulations.
In these Regulations, unless the context otherwise requires, "licensee" means a holder of a licence issued under these Regulations.
3. Application to register an agrochemical
(1) A person may make an application to register an agrochemical in accordance with section 12 of the Act and with the provisions of sub regulation (2).
(2) An application under subsection (1) shall be made to the Registrar in Form 1 set out in the First Schedule and shall further be accompanied by-
(a) two samples of the agrochemical;
(b) any advertising material or experimental data in support of efficacy of the agrochemical;
(c) full toxicological data of the agrochemical;
(d) methods of analysis of the agrochemical; and
(e) residue and phytotoxicity data of the agrochemical under Botswana or similar conditions.
S.I. 36/2005. (f) a fee of P500.
S.I. 36/2005. (2A) An application for the renewal of the registration of an agrochemical shall be made to the Registrar in Form 1 set out in the First Schedule and shall be accompanied by a fee of P250.
S.I. 36/2005. (2B) There shall be charged a fee of P300 for late renewal of registration of an agrochemical.
(3) Where an applicant is only seeking registration for the sale of an agrochemical and the manufacturer of the agrochemical is not prepared to give the applicant information about such agrochemical, the manufacturer shall submit the full composition statement of such agrochemical directly to the Registrar.
(1) The Registrar shall, where he is satisfied that an application meets the requirements of regulation 3, register the agrochemical and issue a registration certificate, as set out in the Second Schedule, to the applicant.
(2) Where the Registrar is not satisfied that the application meets the requirements of regulation 3, he shall reject the application and notify the applicant thereof in writing, stating the reasons for the rejection.
5. Other applications S.I. 36/2005.
(1) An application for-
(a) a temporary import permit shall be in Form 2 and accompanied by a fee of P100;
(b) a permit for the import of an agrochemical for research or experimental purposes shall be in Form 3;
(c) a licence to facilitate the transit of an agrochemical from one country to another country shall be in Form 4 and accompanied by a fee of P200;
(d) a licence to dispose of an agrochemical and its by-products shall be in Form 5 and accompanied by a fee of P200;
(e) a licence to manufacture an agrochemical shall be in Form 6 and accompanied by a fee of P200;
(f) a licence to import, sell or distribute an agrochemical shall be in Form 7 and accompanied by a fee of P200; and
(g) a licence to commercially use an agrochemical shall be in Form 8 and accompanied by a fee of P200.
(2) Where the Registrar is satisfied that an application made in accordance with subregulation (1) meets the requirements of section 16 of the Act and of these Regulations, he shall-
(a) issue a permit as set out in Form 9; or
(b) issue a licence as set out in Form10;
to the applicant, under such terms and conditions as he may consider appropriate.
(3) Where the Registrar is not satisfied that the application meets the requirements of section 16 and of these Regulations, he shall reject the application thereof in writing, stating the reasons for rejection.
(1) All containers in which an agrochemical is offered for sale or distribution shall bear a label written in English, and where possible, in Setswana, firmly affixed to the container, the wording of which shall be approved by the Committee.
(2) An application for the approval of the words to be placed on a label in accordance with sub regulation (1) shall be made to the Committee in writing.
(3) A label in accordance with sub regulation (1) shall contain the information set out in the Third Schedule.
(4) The classification of an agrochemical on a label according to toxicity shall be in accordance with the Fourth Schedule.
(5) The codes to be used for an agrochemical formulation on a label shall be as set out in the Fifth Schedule.
A licensee shall ensure that-
(a) an agrochemical distributed by him is approved, marked, packed and labelled in accordance with the provisions of these Regulations;
(b) the substance contained in an agrochemical distributed by him is in accordance with the specification on the label; and
(c) direction for use and other information printed on the label do not contain misleading or erroneous information.
8. Promotion and advertisement
(1) No person shall issue an advertisement of an agrochemical unless the advertisement has been approved by the Registrar.
(2) The Registrar shall not allow an advertisement that-
(a) uses words or phrases calculated to lead a purchaser to believe that registration or licensing implies special approval or official guarantee of the efficacy of the agrochemical; or
(b) makes claims other than those on a label made in accordance with regulation 6.
A record concerning the importation, manufacture, distribution or sale of an agrochemical maintained in accordance with section 28 of the Act shall contain the following information regarding the agrochemical-
(a) common name;
(b) trade name;
(c) chemical group;
(d) type of formulation;
(e) quantity of the product;
(f) date of manufacture;
(g) expiry date;
(h) toxicity class;
(i) quantity of obsolete chemicals;
(j) intended use;
(k) number of employees; and
(l) training level of employees.
(1) The licensee shall-
(a) ensure that the storage area of an agrochemical-
(i) is kept locked when the licensee or those of his employees handling the agrochemical are absent;
(ii) is well ventilated to prevent the build up of toxic vapours;
(iii) has suitable and adequate fire extinguishers that are easily accessible from outside, and
(iv) has warning signs posted in a conspicuous place, warning people of the dangers of the agrochemical stored inside;
(b) regularly inspect for leaks, any container in which an agrochemical is stored; and
(c) where an agrochemical container is damaged, transfer the agrochemical to a suitable, clean and compatible container and shall label the new container in accordance with these Regulations.
(1) An employer handling an agrochemical shall-
(a) ensure that his employees are medically examined periodically, to ensure that the employees are fit for work involving exposure to the agrochemical;
(b) provide those of his employees handling the agrochemical with appropriate protective clothing, which clothing shall be thoroughly washed at the workplace at the end of each day or operation, particularly when heavily contaminated;
(c) keep and maintain a works exposure record card for each employee handling the agrochemical; and
(d) at all times keep a first aid kit at hand where the agrochemical is manufactured, transported, handled or disposed.
(2) A works exposure record card kept in accordance with subparagraph 1(c) shall provide the following-
(a) the name and address of the employee;
(b) the exposure period of the employee;
(c) the common names of the active ingredient being handled;
(d) the physical state of the formulation of the agrochemical being handled;
(e) details of any occupational accidents involving the employee during the period of exposure;
(f) the date and nature of each case of poisoning; and
(g) a medical practitioners' notes regarding sub regulation (2)(e) and (f).
(3) The employer shall, where an employee falls ill or is involved in an accident at the work place or in the course of discharging his duties as an employee, hand to a medical practitioner who examines the employee, the employee's works exposure record card kept under this regulation.
(1) No person shall-
(a) dump an agrochemical container indiscriminately; or
(b) put an agrochemical into food containers.
(2) A licensee shall ensure that-
(a) cartons, boxes and bags used to carry an agrochemical are shredded to avoid re-use;
(b) agrochemical waste is packed in plastic bags to minimise the risk of exposure during handling;
(c) pallets contaminated by an agrochemical are broken up;
(d) disposal of lightly agrochemical contaminated waste is carried out by-
(i) burning in an incinerator or in a hot fire in an isolated area down wind of the nearest habitation,
(ii) burial in an approved landfill, or
(iii) packing in strong polyethylene bags or 200 litres steel drums for disposal as toxic waste; and
(e) containers that were used to carry an agrochemical are-
(i) well drained, thoroughly rinsed with water or any other appropriate solvent such as diesel fuel then shredded or crushed, or
(ii) returned to the supplier or retained as spares to re-pack the same agrochemical it previously contained or agrochemical contaminated spill.
(1) The Registrar shall regularly conduct a training course for any person who applies for a licence under these Regulations and does not have relevant qualifications.
(2) A course in accordance with sub regulation (1) shall cover the following topics-
(a) interpreting a label;
(b) groups of agrochemicals;
(c) toxicity classes and colour codes;
(d) storage and handling of different types of agrochemicals and agrochemicals with different toxicities;
(e) use of protective clothing; and
(f) disposal techniques of agrochemicals.
A person who contravenes any provision of these Regulations shall be guilty of an offence and liable to a fine not exceeding P500 or to imprisonment for a term not exceeding 6 months, or to both.
FIRST SCHEDULE S.I. 36/2005.
Form 1
APPLICATION FOR THE REGISTRATION OF AN AGROCHEMICAL S.I. 36/2005.
(reg 3(2))
Information for Applicants
1. Please complete all sections fully. Where applicable the required information should be submitted as attachments.
2. The application and product label must be submitted in triplicate.
3. The application must be accompanied by written authority from the manufacturer/formulator.
4. One copy of supportive studies required (e. g toxicological data, efficacy data, residue data, physical specifications etc) Refer to lists I and II attached.
5. Every application must be accompanied by the prescribed registration fees.
6. The application must be submitted to the Registrar of Agrochemicals, Private Bag 0091, Gaborone, Botswana.
Indicate where appropriate:
A.
Agrochemical containing a new active ingredient:
B.
Agrochemical where source of active and/or formulation is not identical to that of a registered product:
C.
Registration transfer:
D.
Amendments to an existing registration:
E.
Other:
1.
APPLICANT
1.1
Identification
Name/Corporate name of company Reg. no.:
(of registration holder)
Name of distributor/agent in Botswana: (if different from registration holder)
1.2
Status:
(Importer/formulator/ distributor)
1.3
Physical Address:
1.4
Postal Address:
1.5
Telephone:
1.6
Fax:
1.7
e-Mail:
2.
PRODUCT
2.1
Designation
Trade name:
Trade mark:
Trade mark holder:
2.2
Function of product (e.g insecticide, herbicide,
2.3
Intended use: (veterinary, agriculture, forestry, public health etc)
2.4
Target pest(s) and host(s):
2.5
Method, dosage rates and frequency of application:
(if required)
2.6
Type of formulation:
Crop Life International/
FAO code:
2.7
Existing reg. no.:
(if relevant)
Customs Tariff Code: (Brussels Tariff Nomenclature)
2.8
Registration in SEARCH country/ies:
2.9
Registration in other country/ies:
2.10
Is the product registered in country of manufacture and formulation:
If not,
why not?
If yes, submit evidence:
3. ACTIVE INGREDIENT(S) (Technical grade) (may be attached in sealed envelope)
Active ingredient(s):
(Common name/s)
Manufacturer:
(Name and address)
Min a.i. % purity:
Range %:
4.
FORMULATION (may be attached in sealed envelope)
4.1
Formulator: (Name)
Address:
4.2
Composition (may be attached in sealed envelope)
Ingredients and Function (e.g emulsifier)
g/l
g/kg
Range
5.
TOXICOLOGY (formulated product)
5.1
RAT:
Acute Oral
(LD50 mg/kg)
Acute Dermal
(LD50 mg/kg)
Inhalation LC50
(mg/l/hour)
Experimental
Experimental
Experimental
Calculated
Calculated
Calculated
5.2
RABBIT:
Skin irritation
Eye irritation
None
Mild
Moderate
Severe
5.3
Sensitisation in guinea pig:
None
Mild
Moderate
Severe
5.4
WHO class:
Ia
Ib
II
III
IV
5.5
Summary of other Mammalian Toxicological Studies:
5.6
Summary of Environmental Effects:
5.6.1
Toxicity to bees:
5.6.2
Toxicity to fish and other aquatic organisms:
5.6.3
Toxicity to birds:
5.6.4
Toxicity to earthworms and soil micro organisms:
5.6.5
Toxicity to other non-target organisms:
5.6.6
Persistence in environment:
5.6.7
Other effects:
6.
PACKAGING
6.1
Packaging material/container:
6.2
Pack size(s):
6.3
Disposal of empty container(s):
7.
STORAGE CONDITIONS
7.1
Temperature
7.2
Humidity
8. DECLARATION BY APPLICANT
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)
.........................................
Signature
..................................................
Date
..........................................
Official Title
FOR OFFICIAL USE
Remarks:
………………...........
………………...........
………………...........
Official Stamp
of Applicant/Company
................... .......................
Signature Date:
Registrar
NOTES:
*Crop Life International
= formerly GCPF (Global Crop Protection Federation), Formerly GIFAP (international Group of National Associations of Manufactures of Agrochemical Products).
** SEARCH
= Southern and East Africa Regulatory Committee for Harmonization of Pesticide Registrations.
ACTIVE INGREDIENT: DOSSIER INDEX
List I
The dossier accompanying the form should provide more details of the information requested in the list i.e. details on the methods used, applicants are advised to use CIPAC methods for physical and Chemical properties, summaries of the methods and results used in toxicology and ecotoxicological studies, methods of analysis etc. Numbering used in the dossier must follow that used in the application form. If the product contains more than one active ingredient, compile a separate dossier for each active ingredient)
ACTIVE INGREDIENT
(Technical grade)
1.
a.name (ISO)
b.or development code
c.name (IUPAC)
d.group
e.formula
f.formula
g.status
the a.i. under patent
Who is patent holder
Expiry date
2.
PHYSICAL AND CHEMICAL PROPERTIES
(active ingredient – technical grade)
a.state
b.
c.
d.at 20°C
e.pressure at 20/25°C
f.
g.DT50.........Days........°C....pH
h.
i.in water.............°C..............pH
j.organic solvents
k.octanol/water partition coefficient
l.point °C
m.point °C
n.temperature °C
o.of Analysis and Impurities
3.
(Active Ingredient – technical grade)
a.
b.oral LD50 mg/kg rat/rabbit
c.dermal LD50 mg/kg rat
d.LC50 mg/l /hour (rat)
e.irritation (rabbit)
f.irritation (rabbit)
g.(guinea pig)
h.(specify species)
i.toxicity 90 day NOEL mg/kg/day
j.toxicity NOEL mg./kg/day
k.(life time) NOEL mg/kg/day
l.NOEL mg/kg/day
m.ogenicity NOEL mg/kg/day
n./ Genotoxicity
o.(rat)
p.studies
4.
ECOTOXICOLOGY
(Active ingredient – technical grade)
a.
Birds (2 species)
LD50 mg/kg
NOEL
LD50 mg/kg
NOEL
Reproduction
b.
Fish (2 species)
LD50 mg/kg
NOEL
LD50 mg/kg
NOEL
Reproduction
BCP
c.
Daphnia
LC50 mg/l
NOEL
d.
Algae
LC50 mg/l
NOEL
e.
Bees
LD50
NOEL
f.
Earthworms
LC50 mg/kg
g.
Soil micro-organisms
5.
BEHAVIOUR IN ENVIRONMENT
(active ingredient – technical grade)
Behaviour, ways of degradation, degradation products in soil:
a.
Major metabolites
b.
DT50 (days)
c.
Mobility
d.
Adsorption
e.
Mobility of metabolites
Behaviour, ways of degradation, degradation products in water:
f.
Major Metabolites
g.
DT50 (days)
h.
Surface
i.
Ground
6.
Mode of action
7.
RESIDUES IN THE PLANT
a.
Major metabolites
b.
Metabolism
c.
Behaviour of residues
d.
Crop
e.
MRL codex
f.
MRL country
g.
PHI & MRL proposed
h.
Method of residue analysis
8.
COUNTRY SPECIFIC REQUIREMENTS
a.
b.
c.
d.
e.
f.
FORMULATED PRODUCT: DOSSIER INDEX
List II
The dossier accompanying the form should provide more details of the information requested in the list i.e. details on the methods used, applicants are advised to use CIPAC methods for physical and Chemical properties, summaries of the methods and results used in toxicology and ecotoxicological studies, methods of analysis etc. Numbering used in the dossier must follow that used in the application form.
FORMULATED PRODUCT
Annex, No. in dossie if study included
Official use only
1.
PHYSICAL AND CHEMICAL PROPERTIES
a.
Physical state/formulation type
b.
Colour
c.
Odour
d.
Storage stability
e.
Shelf life
f.
Density
g.
Bulk density
h.
Flammability
i.
Flash Point
j.
Compatibility with other pesticides
k.
pH
l.
pH of 1% aqueous dilution
m.
Oxidizing properties
n.
Corrosiveness
o.
Water content
p.
Wettability
q.
Solubility in water
r.
Foaming
s.
Particle size
t.
Suspensibility/emulsifiability
u.
Emulsion stability
v.
Volatility
w.
Viscosity
x.
Other properties (where applicable)
y.
Method of Analysis
2.
TOXICOLOGY
a.
Rat
Acute oral LD50 mg/kg
b.
Acute dermal LD50 mg/kg
c.
Inhalation LC50 mg/l /hour
d.
Rabbit
Skin irritation
e.
Eye irritation
f.
Sensitisation in guinea pig
g.
WHO classification
h.
Other studies
3.
EMERGENCY PROCEDURES IN CASE OF ACCIDENTAL EXPOSURE OR POISONING
a.
Symptoms of human poisoning
b.
First aid treatment
c.
Skin contact
d.
Eye contact
e.
Inhalation
f.
Ingestion
g.
Antidote
h.
Note to physician
4.
EMERGENCY PROCEDURES IN CASE OF FIRE/SPILLAGE
a.
Fire fighting measures
b.
Procedures in case of spillage
5.
USES (New label claims with this application)
a.
Crop/area of use
b.
Target organism
c.
Rate
d.
Stage of treatment
e.
Directions for use
f.
Residue data and pre-harvest interval
g.
Phytotoxicity
h.
Contraindications
6.
MINIMUM LABEL REQUIREMENTS
a.
Product identification
b.
Warnings and use restrictions
c.
Safety precautions
d.
First aid/note to physician (as applicable)
e.
Pictograms (if applicable)
f.
FAO colour code (if applicable)/group
g.
Directions for use
7.
STORAGE CONDITIONS
a.
Temperature
b.
Humidity
Form 2
APPLICATION FOR A TEMPORARY IMPORT PERMIT S.I. 36/2005.
(reg 5(1)(a))
I/ We..........................................................................................................................
Of (mailing address)
............................................................................................
............................................................................................
............................................................................................
wish to import the following agrochemical(s)
Product Name
Active Ingredient
Registration Number
Country of Origin
Quantity
The importation will be made during the period .............................to .............................
Signature ...................................................................
Date ...................................................................
Form 3
APPLICATION FOR A PERMIT FOR THE IMPORT OF AN AGROCHEMICAL FOR RESEARCH OR EXPERIMENTAL PURPOSES
(reg 5(1)(b))
Name of applicant.............................................................................................................
Postal address.
........................................................................................................
........................................................................................................
........................................................................................................
Tel no.
........................................................................................................
Physical address
........................................................................................................
........................................................................................................
Tel no.
........................................................................................................
Common name of the agrochemical(s)................................................................................
.............................................................
............................................................
Trade name(s) or code number of the agrochemical.............................................................
............................................................
............................................................
Chemical name(s) of the agrochemical...............................................................................
............................................................
.............................................................
Main active ingredient(s) ...................................................................................................
Type of agrochemical .......................................................................................................
Type of formulation ..........................................................................................................
Classification according to Botswana system ....................................................................
Dermal and oral mammalian toxicity .................................................................................
Amount of agrochemical being imported ............................................................................
Intended use of the agrochemical.......................................................................................
.......................................................................................................................................
.......................................................................................................................................
Place(s) where the agrochemical will be used .....................................................................
.......................................................................................................................................
.......................................................................................................................................
Name and qualifications of officer in charge of research or experiment ..................................
......................................................................................................................................
Signature ...........................................................
Date...................................................................
Form 4
APPLICATION FOR A LICENCE TO FACILITATE THE TRANSIT OF AN AGROCHEMICAL FROM ONE COUNTRY TO ANOTHER
(reg 5(1)(c))
Name of applicant ............................................................................................................
Postal address ................................................................................................................
Name of the agrochemical ................................................................................................
Quantities of the agrochemical...........................................................................................
Type of packaging.............................................................................................................
Type of warning signs on the consignment..........................................................................
Mode of transport .............................................................................................................
Country of origin ...............................................................................................................
Country of destination........................................................................................................
Entry point .......................................................................................................................
Exit point .........................................................................................................................
Intended date of entry........................................................................................................
Intended date of exit..........................................................................................................
Name of officer in charge of the consignment.......................................................................
Address ..........................................................................................................................
Tel no. ...........................................................
Signature of authorised officer.............................................................................................
Date.................................................................................................................................
NOTE: PLEASE ATTACH LETTER OF CONSENT FROM INTENDED RECIPIENT OF THE CONSIGNMENT.
Form 5
APPLICATION FOR A LICENCE TO DISPOSE OF AN AGROCHEMICAL AND ITS BY-PRODUCTS
(reg 5(1)(d))
Name of applicant ..........................................................................................................
Postal address ..........................................................................................................
Physical address ..........................................................................................................
.........................................................................................................
.........................................................................................................
Tel no. .........................................................................................................
Physical address .........................................................................................................
.........................................................................................................
.........................................................................................................
Tel no. .........................................................................................................
Name of agrochemical.....................................................................................................
Formulation....................................................................................................................
Container type.................................................................................................................
Quantities to be disposed.................................................................................................
Method of disposal...........................................................................................................
Place where disposal operation will take place....................................................................
Date of intended disposal operation ...................................................................................
Name of officer in charge of the disposal operation...............................................................
Qualifications of officer in charge of the disposal operation....................................................
.......................................................................................................................................
Signature..........................................................
Date..................................................................
Form 6
APPLICATION FOR A LICENCE TO MANUFACTURE AN AGROCHEMICAL
(reg 5(1)(e))
Name of applicant ...........................................................................................................
Postal address ...............................................................................................................
........................................................................................................................
........................................................................................................................
Tel no.............................................................................................................................
Physical address .........................................................................................................
.........................................................................................................
Tel no.............................................................................................................................
Product to be manufactured..............................................................................................
...............................................................................................
Quantities intended to be produced per annum..................................................................
Use of the formulated final product ...................................................................................
Signature..................................................................
Date.........................................................................
Form 7
APPLICATION FOR A LICENCE TO IMPORT, SELL OR DISTRIBUTE AN AGROCHEMICAL
(reg 5(1)(f))
Name of applicant ...........................................................................................................
Postal address. ..............................................................................................................
Physical address. .......................................................................................................
.......................................................................................................
.......................................................................................................
Tel no.............................................................................................................................
Agrochemicals to be imported, sold or distributed...............................................................
......................................................................................................................................
......................................................................................................................................
Type...............................................................................................................................
Formulation ....................................................................................................................
Quantities ......................................................................................................................
Intended uses ................................................................................................................
Registration numbers(s) of the products............................................................................
......................................................................................................................................
......................................................................................................................................
......................................................................................................................................
Country of origin ..............................................................................................................
Date of manufacture.........................................................................................................
Registration number in country of origin..............................................................................
Name and qualification of officer in charge..........................................................................
......................................................................................................................................
Signature ...................................................................
Date...........................................................................
Form 8
APPLICATION FOR A LICENCE TO COMMERCIALLY USE AN AGROCHEMICAL S.I. 36/2005.
(reg 5(1)(g))
Name of applicant
.................................................................................................
Postal address
.................................................................................................
Telephone Number
.................................................................................................
Physical address
.................................................................................................
Telephone Number
.................................................................................................
Type of application (pest, weed control fertilizer application, etc)
......................................................................................................................................
Application equipment to be used
......................................................................................................................................
Name and qualifications of technical staff in charge
......................................................................................................................................
Signature ........................................
Date ........................................
Form 9
AGROCHEMICALS IMPORT PERMIT S.I. 36/2005
(reg 5(2))
Indicate by ticking the appropriate:
I. (a) Import Permit .............…………….. (for research or experimental purposes)
(b) Temporary Import Permit …….............……….. (for own use)
Permit No. ................................ issued on............................... under Regulation 5 of the Agrochemicals Regulations, made thereunder
To ............................................................................................................................. .............
(Name and Company) whereas the said permit holder is hereby granted a permit to import the following agrochemicals:
Product Name
Active Ingredient
Registration Number
Country of Origin
Quantity
__________________________________________________________________________
__________________________________________________________________________
for the period from..................................................to ...................................................
Permit is subject to the following conditions:
1. According to the Agrochemicals Act (Cap. 35:09) and Agrochemicals Regulations (Cap. 35:09 (Sub. Leg.)).
2. As per attached conditions
Signature..................................................
Registrar
Date.........................................................
Official Stamp
Form 10
AGROCHEMICALS LICENCE S.I. 36/2005
(reg 5(2))
Licence No. ..................................... issued on .......................... under Regulation 5 of
the Agrochemicals Regulations, made thereunder
To:..................................................................................................................................
......................................................................................................................................
(Name and Company) whereas the said licence holder is hereby granted a license for
......................................................................................................................................
......................................................................................................................................
......................................................................................................................................
......................................................................................................................................
for the period from .......................................to ...........................................
Licensing is subject to the following conditions:
1. According the Agrochemicals Act (Cap. 35:09) and Agrochemicals Regulations.
2. As per attached conditions
Signature..................................................
Registrar
Date.........................................................
Official Stamp
SECOND SCHEDULE
AGROCHEMICAL REGISTRATION CERTIFICATE
(reg 4)
Agrochemical Registration Certificate number.....................................................................
Category of registration.....................................................................................................
Common name.................................................................................................................
Trade name .....................................................................................................................
Name and address of applicant ........................................................................................
......................................................................................................................................
......................................................................................................................................
......................................................................................................................................
This is to certify that the above mentioned agrochemical has been approved and registered for sale or use in Botswana under conditions detailed below:
.....................................................................................................................................
.....................................................................................................................................
.....................................................................................................................................
.....................................................................................................................................
This certificate is valid until...............................................................................................
Signature ....................................................................................
Registrar
Date...........................................................................................
THIRD SCHEDULE
INFORMATION TO BE WRITTEN ON A LABEL S.I. 36/2005.
(reg 6(3))
A label shall show -
(a) the trade name of the agrochemical;
(b) the international common (standard) name or the chemical formula of the active ingredient contained in the agrochemical, the formulation of the agrochemical and the purpose for which the agrochemical is to be used;
(c) the classification of the agrochemical according to toxicity in accordance with the Fourth Schedule;
(d) warning signs printed in letters which are clear and distinct, and pictograms shall be used whenever possible;
(e) the net weight or volume content of the container;
(f) directions for use and compatibility with other preparations:
Provided that if the container is too small to allow sufficient space for directions for use, directions may be inserted inside the container for solid formulations or be affixed to the container, but not in such a way that danger signs and toxicity class markings are concealed;
(g) the name and address of the manufacturer, distributor or agent of the agrochemical;
(h) the registration number provided by the Committee;
(i) the date of manufacture and the maximum shelve time of the agrochemical;
(j) the content in the product of each of the active ingredients and their chemical description and the total content of other substances in the agrochemical;
(k) a statement, when required of the pre-harvest interval or the period which should elapse between the last application of the agrochemical and the -
(a) harvest of the plant;
(b) grazing of treated areas;
(c) slaughter of treated animals for food;
(d) feeding produce;
(e) planting of subsequent crops;
(l) the batch number of the agrochemical; and
(m) first aid instructions and advice to doctors regarding exposure to the agrochemical.
PESTICIDES label LAYOUT (Based on the FAO three panel label)
LEFT PANEL:
CENTRE OR SALES PANEL:
RIGHT PANEL:
BEFORE USING THIS PRODUCT READ the LABEL CAREFULLY!
SAFETY & PRECAUTIONS:
PRODUCT NAME
DIRECTION FOR USE:
Disposal methods
Storage conditions
Concentration of active ingredient and formulation type.
Mixing instructions:
WARNING PHRASES:
Description of product and summary of uses.
Application Rate:
Compatibility:
SYMPTOMS OF POISONING:
Product Group Code according to mode of action (according to IRAC, FRAC or HRAC code system).
Ground Application
FIRST AID:
KEEP LOCKED UP OUT OF REACH OF CHILDREN
Aerial application (when applicable):
Registration number of Act no. xxx of xxx
ADVICE TO DOCTOR: (specify antidote if available)
Country of Origin:
Manufacturer:
RE-ENTRY PERIOD:
(when applicable)
RESISTANCE WARNING:
Distributor, agent:
PRE-HARVEST INTERVAL:
Manufacturing date:
USE RESTRICTIONS:
Expiry date/Shelf life:
LEGAL RESPONSIBILITY/ WARRANTY:
WAITING PERIODS FOR FOLLOW-UP CROPS: (when applicable)
Batch number:
Net content:
Trade mark acknowledgement.:
Colour code/Hazard symbol - According to WHO Hazard classification.
FOURTH SCHEDULE
CLASSIFICATION OF AGROCHEMICALS ACCORDING TO TOXICITY S.I. 36/2005.
(reg 6(4))
Toxicity Class
Colour Code
Hazard Statement/Symbol
Acute LD50 for the rat(mg/kg)
Oral
Dermal
Solid
Liquid
Solid
Liquid
1a Extremely hazardous
Red
Very toxic/skull and cross bones
5 or less
20 or less
10 or less
40 or less
1b Highly hazardous
Red
Toxic/skull and cross bones
5-50
20-200
10-100
40-400
II Moderately hazardous
Yellow
Harmful
50-500
200-2000
100-100
400-400
III Slightly hazardous
Blue
Caution
>500
>2000
>1000
>4000
IV Unlikely to be hazardous in normal Use Green
Green
-
-
-
-
FIFTH SCHEDULE
CODES TO BE USED FOR AGROCHEMICALS FORMULATIONS
(reg 6(5))
Code
Formulation Type
AB
Grain bait
AE
Aerosol generator
AL
Other liquids to be applied undiluted
BB
Block bait
BR
Briquette
CB
Bait concentrate
CG
Encapsulated granule
CS
Capsule suspension
DC
Dispersible concentrate
DP
Dustable powder
DS
Powder for seed treatment
EC
Emulsifiable concentrate
ED
Electrochargeable liquid
EO
Emulsion, water in oil
ES
Emulsion for seed treatment
EW
Emulsion, oil in water
FD
Smoke tin
FG
Fine granule
FK
Smoke candle
FP
Smoke cartridge
FR
Smoke rodlet
FS
Flowable concentrate for seed treatment
FT
Smoke tablet
FU
Smoke generator
FW
Smoke pellet
GA
Gas
GB
Granular bait
GE
Gas generating product
GG
Magrogranule
GP
Flo-dust
GR
Granule
GS
Grease
HN
Hot fogging concentrate
KN
Cold fogging concentrate
LA
Lacquer
LS
Solution for seed treatment
MG
Microgranuel
OF
Oil miscible suspension/flowable concentrate
OL
Oil miscible liquid
OP
Oil dispersible powder
PA
Paste
PB
Plate bait
PC
Gel or paste concentrate
PO
Pour-on
PR
Plant rodlet
PS
Seed coated with a pesticide
RB
Ready to use bait
SA
Spot on
SB
Scrap bait
SC
Suspension concentrate
SG
Water soluble granules
SL
Soluble concentrate
SO
Spreading concentrate
SP
Water soluble powder
SS
Water soluble powder for seed treatment
SU
Ultra low volume suspension
TB
Tablet
TC
Technical material
TK
Technical concentrate
TP
Tracking powder
UL
Ultra low volume liquid
VP
Vapour releasing product
WG
Water dispersible granules
WP
Wettable powder
WS
Water dispersible powder for slurry treatment
XX
Others
