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THE PEST CONTROL PRODUCTS (LICENSING OF PREMISES) REGULATIONS, 1984
ARRANGEMENT OF REGULATIONS
| 2. |
Premises not to be used unless licensed
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| 3. |
Application for licensing of premises
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| 4. |
Issue and expiry of licence
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| 5. |
Layout and construction of manufacturing, formulating, packaging and storing premises
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| 6. |
Protection of workers and operators and quality of products
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| 7. |
Essential requirements for operations, etc.
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SCHEDULES
THE PEST CONTROL PRODUCTS (DISPOSAL) REGULATIONS, 2006
| 1. |
Citation
These Regulations may be cited as the Pest Control Products (Disposal) Regulations, 2006.
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| 2. |
Disposal of pest control products for commercial purpose
| (1) |
No person shall dispose of any pest control product or their containers in a manner that shall be detrimental to man, animal and the environment.
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| (2) |
No person shall carry out any disposal of pest control product or containers for commercial purposes unless that person or institution is in possession of a licence under these Regulations and all provisions of the Act have been complied with.
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| (3) |
The use of any pest control product disposal method shall be approved by the Board subject to specific requirements laid down by the Board.
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| (4) |
The transboundary movements of pesticides for disposal shall be subject to ratified conventions, protocols, treaties or agreements to which Kenya is a party.
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| (5) |
Without prejudice to the provisions of the Environmental Management and Co-ordination Act, any person or institution desiring a licence for disposal of pest control products for commercial purposes shall apply to the Board for a licence in the prescribed Form A set out in the Schedule and shall be accompanied by the prescribed fees.
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| 3. |
Application for disposal licence
| (1) |
The Board may approve an application made under Regulation 2 and shall issue a licence as set out in Form B in the Schedule if it is satisfied that:
| (a) |
the application contains the information required under these regulations;
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| (b) |
approved methods of disposal would be used or applied;
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| (c) |
the applicant has sufficient expertise to dispose of the pest control products in question.
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| (2) |
Disposal for commercial purposes shall be supervised by the Board which shall issue a certificate of disposal in the prescribed Form C in the Schedule after successful disposal.
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| (3) |
Where the Board does not approve an application it shall not be obliged to give any reason thereof.
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| (4) |
The Board may attach to a licence such conditions as it deems fit.
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| (5) |
No person or institution to which a licence has been issued under these Regulations shall lend, hire, sell, transfer or otherwise dispose of that licence to any person or institution without the approval of the Board, which approval shall be endorsed on the licence.
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| 4. |
Cancellation or suspension of licence
| (1) |
The Board may cancel or suspend for a period it deems fit the licence issued under these Regulations if satisfied that-
| (a) |
the licensee, his servant or agent has been convicted of an offence under the Act; or
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| (b) |
the licensee, his servant or agent has breached any of the terms or conditions of the licence; or
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| (c) |
for any other reason, that it is in public interest to do so.
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| (2) |
Before cancelling or suspending a licence under this regulation, the Board shall give the licensee twenty-one days' notice to show cause why the licence should not be cancelled or suspended and the Board's decision in the matter shall be final.
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THE PEST CONTROL PRODUCTS (LICENSING OF PREMISES) REGULATIONS, 1984
| 1. |
Citation
These Regulations may be cited as the Pest Control Products (Licensing of Premises) Regulations, 1984.
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| 2. |
Premises not to be used unless licensed
| (1) |
No person shall use any premises, or being the owner or occupier thereof permit or allow the premises to be used, for the purposes of manufacturing, formulating, packaging, selling or storing pest control products unless that person is in possession of a licence issued under these Regulations in respect of those premises.
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| (2) |
No person shall operate any business in pest control unless that person is in possession of a license issued under these regulations in respect of that business.
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| (3) |
No licence shall be issued under these Regulations as set out in Form C in the Schedule unless the Board is satisfied that the provisions of these Regulations have been complied with.
[L.N. 124/2006, r. 2.]
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| 3. |
Application for licensing of premises
| (1) |
An application for a licence under these Regulations shall be in Form A in the Schedule.
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| (2) |
An applicant for a licence shall, on request by the Board, supply any information that may be required for the purposes of these Regulations.
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| 4. |
Issue and expiry of licence
| (1) |
Every licence issued under these Regulations shall be in Form B in the Schedule, and shall expire on the 31st December next following the date of issue.
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| (2) |
No person to whom a licence has been issued under these Regulations shall lend, hire, sell, transfer or otherwise dispose of that licence without the approval of the Board, which approval shall be endorsed on the licence.
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| (3) |
No licence shall be transferred from the premises in respect of which it was issued.
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| (4) |
A licence issued by the Board under regulation 4(1) may be cancelled, suspended or revoked by the Board if the holder of such a licence contravenes the provisions of the Act or the Regulations made under it.
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| (5) |
The information on licence cancellation, suspension or revocation under 4(4) shall be made known to the holder in writing and the general public by Gazette notice.
[L.N. 124/2006, r. 3.]
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| 5. |
Layout and construction of manufacturing, formulating, packaging and storing premises
All premises used for the manufacturing, formulating, packaging and storing of pest control products shall—
| (a) |
be of a suitable design, layout and construction to ensure the health of workers and to avoid contamination of the environment;
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| (b) |
have sufficient space for the placement of equipment and storage of materials which is necessary for the health of workers and operators;
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| (c) |
have separate areas, either by partition, location or other effective means, for those operations which do not require workers to be exposed to pest control products.
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| 6. |
Protection of workers and operators and quality of products
Every person who owns, operates or is in charge of premises used for the manufacturing, formulating, packaging and storing of pest control products shall ensure that—
| (a) |
| (i) |
the persons working in the premises wear adequate protective clothing; |
| (ii) |
the premises are well supplied with first-aid facilities to the satisfaction of the Board to cater for accidental poisoning; |
| (iii) |
the general health of the persons working on the premises is adequately catered for; and |
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| (b) |
the quality of the products are within the prescribed limits.
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| 7. |
Essential requirements for operations, etc.
Every person who owns, operates or is in charge of—
| (a) |
premises in which the manufacturing, formulating, packaging and storing of a pest control product is undertaken shall have adequate knowledge of the chemistry, toxicology, efficacy and general use of the product being dealt with to the satisfaction of the Board;
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| (b) |
premises licensed under these Regulations shall ensure that the products are packaged and labeled as required by the provisions of this Act and the Regulations and shall keep stock records for a minimum of five years;
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| (c) |
pest control product stores and other dispensing premises shall have adequate knowledge of efficacy, uses and handling precautions of all pest control products within the premises to the satisfaction of the Board;
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| (d) |
premises licensed under these Regulations shall provide adequate water and general cleanliness to facilitate safe dispensing of the products; ensure physical separation of pest control products stores from food stores and keep stock records for all pest control products in the premises.
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| 8. |
Permits
| (1) |
Any person who intends to handle, use, distribute, transport or deal in a Pest Control Product under restricted class shall apply to the Board for a permit in the prescribed Form D in the Schedule.
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| (2) |
No person shall handle, use, distribute, transport or deal in a Pest Control Product under restricted class without a permit from the Board in the prescribed Form E in the Schedule.
[L.N. 124/2006, r. 7.]
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THE PEST CONTROL PRODUCTS (REGISTRATION) REGULATIONS, 1984
ARRANGEMENT OF REGULATIONS
| 3. |
Exemption from registration
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| 4. |
Application for registration of pest control products
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| 4A. |
Application for registration of a synthetic or conventional pest control product
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| 4B. |
Application for the registration of microbial biopesticide
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| 4C. |
Application for the registration of macrobial biopesticide
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| 4D. |
Application form for the registration of a biochemical pesticide other than semiochemicals
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| 4E. |
Application form for registration of spray adjuvants
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| 4F. |
Registration of a parallel/daughter pest control product
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| 4G. |
Extension of the use of a registered pest control product
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| 5. |
Applicant to provide samples
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| 7. |
Issue of certificate of registration
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| 9. |
Temporary registration
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| 10. |
Refusal to register pest control
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| 11. |
Suspension and revocation of certificates of registration
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| 12. |
Notice to holder of certificate of registration, etc.
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| 15. |
Declared source of product
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SCHEDULES
THE PEST CONTROL PRODUCTS (LICENCE FEES AND OTHER CHARGES) REGULATIONS, 2006
| 1. |
Citation
These Regulations may be cited as the Pest Control Products (Licence Fees and Other Charges) Regulations, 2006.
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| 2. |
Fees payable
The fees payable to the Board by any person for services rendered by the Board shall be as prescribed by the Board from time to time as set out in the Schedule and the fees chargeable shall be added in case of combination of businesses in category I in the Schedule.
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| 3. |
Charges for supervision services
The charges for supervision services rendered by the Board shall be as prescribed by the Board from time to time as set out in the Schedule.
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| 4. |
Import fee
The Board may charge an import fee at the rate of 0.8% free on board (F.O.B.) value of the product and shall be paid to the Board as agreed with the Agrochemicals Association of Kenya of which 0.4% shall be used by the Board to train end-users and other stake holders on safe use of products and the remaining 0.4% shall be remitted by the Board to the Association for the same purpose of training.
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SCHEDULE
LICENSING OF PREMISES
THE PEST CONTROL PRODUCTS (LABELLING, ADVERTISING AND PACKAGING) REGULATIONS, 1984
| 1. |
Citation
These Regulations may be cited as the Pest Control Products (Labelling, Advertising and Packaging) Regulations, 1984.
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| 2. |
Interpretation
In these Regulations, unless the context otherwise requires—
"display panel" means part of a label applied on or affixed to the package of a pest control product but does not include a leaflet or brochure unless it is part of the label;
"Formulator" means a person who prepares the active ingredient of a pest control product into a form which is convenient for its intended use;
"Re-packer" means a person who puts a formulated product into appropriate unit sizes.
[L.N. 127/2006, r. 2.]
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| 3. |
Labelling requirements
| (1) |
No pest control product shall be distributed or sold without a label.
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| (2) |
No label shall be used on a pest control product unless it has been approved by the Board and, unless the Board otherwise directs, every label shall show—
| (a) |
the name of a pest control product which shall be descriptive of the physical form and the purpose of the pest control product and shall include the common name of its active ingredients and may include a distinctive brand or trade mark;
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| (b) |
the class designation of the pest control product in capital letters and shall be classified as set out in the First Schedule;
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| (c) |
information detailing the nature and degree of hazard inherent in the pest control product and the nature and degree of hazard shall be identified by the appropriate precautionary symbol and signal words selected from the Second Schedule together with a statement respecting the nature of the primary hazard to which the symbol relates;
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| (d) |
a statement directing the user to read the label which statement shall be in the following form – "READ THE LABEL BEFORE USING";
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| (e) |
a guarantee statement in the following manner—
| (i) |
the word in capital letters "GUARANTEE", followed by; |
| (ii) |
a colon; followed by; |
| (iii) |
the common name of the active ingredient of pest control product or where a common name has not been designated, the chemical or other name of the active ingredient; followed by; |
| (iv) |
the contents of the active ingredient expressed— |
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| (f) |
the registration number of the pest control product which shall be set out in the following manner—
"REGISTRATION NO. PCPB (CR) 0000" AND PCPB (TCR) 0000";
Where "CR" means Certificate of Registration for a period of three years and or renewal for a period not exceeding two years at any one time; and "TCR" means Temporary Certificate of Registration for a period not exceeding one year;
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| (g) |
a statement of the net contents of the package for the pest control product, which shall be expressed—
| (i) |
in the case of a liquid pest control product of a volume less than one litre, in terms of millilitres; |
| (ii) |
in the case of a liquid pest control product of a volume of one litre or more, in terms of litres; |
| (iii) |
in the case of a pressure-packed pest control product in terms of weight, in grams if less than one kilogram; |
| (iv) |
in the case of a pressure-packed pest control product which weighs one kilogram or more, in terms of kilograms; |
| (v) |
in the case of a dry formulation pest control product which weighs less than a kilogram, in terms of grams; |
| (vi) |
in the case of a dry formulation pest control product which weighs one kilogram or more, in terms of kilograms; |
| (vii) |
in the case of a pest control product that is semi-solid or viscous in terms of either weight or volume in accordance with this paragraph; or |
| (viii) |
in the case of a pest control product the nature of which does not lend itself to net content statements prescribed in this paragraph, in terms acceptable to the Board; |
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| (h) |
the name and postal address of the registrant and the name and postal address of the resident agent, if any and the names and postal addresses of manufacturer, formulator, distributor and re-packer;
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| (i) |
the directions for use of the pest control product, which directions shall include dosage rates, timing of application and use limitations;
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| (j) |
information identifying any significant hazards respecting the handling, storage, display, distribution and disposal of the pest control product which information shall include instructions respecting procedures to alleviate the hazard and when required by the Board, instructions respecting decontamination procedures and disposal of the pest control product and the empty package;
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| (k) |
information identifying any significant hazard to—
| (i) |
things on or in relation to which the pest control product is intended to be used; or |
| (ii) |
public health, plants, animals or the environment, which information shall include instructions respecting the procedures to alleviate any such hazard; |
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| (l) |
instructions for first aid, which instructions shall be under the heading in capital letters "FIRST AID INSTRUCTIONS" and shall set out the practical measures to be taken in the event of poisoning or other injury caused by the pest control product;
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| (m) |
the toxicological information essential to the treatment of a person poisoned or otherwise injured by the pest control product, which information shall be under the heading in capital letters "TOXICOLOGICAL INFORMATION" and shall—
| (i) |
describe the symptoms of poisoning; |
| (ii) |
state antidotes and remedial measures; and |
| (iii) |
state the ingredient that may affect the treatment; |
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| (n) |
a notice to the user of the pest control product which notice shall be in the following manner;
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This pest control product is to be used only in accordance with the directions on this label. It is an offence under the Pest Control Products Act (Cap. 346) to use or store a pest control product under unsafe conditions;
| (o) |
the colour codes banding precautionary pictograms relating to the toxicity of the product in the following manner of declining toxicity—
| (i) |
PMS Red 199C for products classified under WHO class Ia and Ib; |
| (ii) |
PMS yellow C for products classified under WHO class II; |
| (iii) |
PMS Blue 293C for products classified under WHO class III; |
| (iv) |
PMS Green 347C for unclassified products under WHO classification; |
| (v) |
the colour shall not be used elsewhere on the label; and |
| (vi) |
any other pictogram as directed by the Board; |
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| (p) |
separate pictograms depicting at least one pest controlled by the pest control product and crop or animal or other usage as registered under this Act;
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| (q) |
an instruction directing the user on storage which shall be in capital letters– KEEP LOCKED OUT OF REACH OF CHILDREN;
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| (r) |
information on the date of manufacture, expiry date, batch number and shelf-life if stored in original container under cool dry conditions.
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| (3) |
The label for a pest control product which is a device of a type or kind listed in the First Schedule to the Pest Control Products (Registration) Regulations shall contain the information referred to in subparagraphs (f), (h), (i), (j), and (k) of paragraph (2).
[L.N. 127/2006, r. 3.]
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| 4. |
Display panels
| (1) |
The display panel shall consist of one principal display panel and at least one secondary display panel.
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| (2) |
Where the primary purpose of a pest control product is not to control, prevent, destroy, mitigate, attract or repel a pest, but it has these properties, the pest control product shall have a display panel with—
| (a) |
the information referred to in subparagraphs (a), (b), (c), (d), (g) and (h) of regulation 3(2) on the principal display panel; and
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| (b) |
the information referred to in subparagraphs (e), (f), (i), (l) and (m) of regulation 3(2) on the secondary display panel.
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| (3) |
Where the primary purpose of a pest control product is to control, prevent, destroy, mitigate, attract or repel a pest, the pest control product shall have a display panel with the information referred to in subparagraphs (a), (b), (c), (d), (e), (f), (g) and (h) of regulation 3(2) on the principal display panel.
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| (4) |
This Regulation shall apply to a label for a pest control product that is within the meaning of paragraph (a) of the definition of "pest control product" in section 2 of the Act.
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| 5. |
Notice on display panel
| (1) |
Where the principal display panel shows the pest control product as "RESTRICTED", the notice referred to in regulation 3(2)(n) shall appear prominently at the top of the secondary display panel followed by the heading in capital letters "RESTRICTED USE", followed by the directions for use, dosage, timing of application and use limitations to which the restrictions relates all of which shall be circumscribed by a line to set the information apart from all other information required to be shown on the secondary display panel.
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| (2) |
Notwithstanding paragraph (1), where the principle display panel shows the pest control product as "RESTRICTED" the directions for use, dosage rates, timing of application and use limitations to which the restriction relates, together with the information referred to in subparagraphs (a), (b), (c), (d), (e), (f), (g), (h) and (i) of regulation 3(2) may, with the approval of the Board, appear in a brochure or leaflet that will accompany the package for the pest control product.
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| (3) |
Where the information required to be shown on the label is not included in the display panel, the display panel shall contain the words in capital letters "READ ATTACHED BROCHURE BEFORE USE" prominently displayed thereon.
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| 6. |
Display of additional information
| (1) |
Subject to the approval of the Board, additional information relating to the pest control product and any graphic design or symbol maybe shown on the label if it does not unreasonably detract or obscure the information required to be shown on the label under these Regulations.
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| (2) |
A registrant may include on the label the following liability limitation warranty—
Seller’s guarantee is limited to the terms set out on the label and subject thereto, the buyer assumes the risk to persons or property arising from the use or handling of this product and accepts the product on that condition.
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| 7. |
Information where product is distributed in bulk
Where a pest control product is distributed in a bulk container, the information referred to in subparagraphs (a), (b), (e), (f), (g), (h), (i) and (m) of regulation 3(2) shall be shown—
| (a) |
on the bulk container; and
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| (b) |
on the documents respecting the pest control product or on a statement accompanying the consignment.
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| 8. |
Information on label
| (1) |
The information on every label shall be printed in both English and Kiswahili languages.
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| (2) |
All units of measures shown on the label shall be expressed in accordance with the requirements of the Weights and Measures Act (Cap. 513).
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| (3) |
All information shown on the label shall be printed in a manner that is conspicuous, legible and indelible.
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| 9. |
Denaturation
Where the physical properties of a pest control product are such that the presence of the pest control product may not be recognized when it is used, and is likely to expose a person or domestic animal to a severe health risk, the pest control product shall be denatured by means of colour, odour or such other means as the Board may approve to provide signal or warning of its presence.
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| 10. |
Storage and display
A pest control product shall be stored and displayed in accordance with the conditions shown on the label.
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| 11. |
Distribution
Notwithstanding the provisions of the Pharmacy and Poisons Act (Cap. 244), a pest control product shall be distributed in accordance with such condition as the Board shall specify.
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| 12. |
Prohibition
No person shall use a pest control product in a manner that is inconsistent with the directions or limitations respecting its use as shown on the label.
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| 13. |
Packaging
| (1) |
Every package for a pest control product shall, unless the Board otherwise directs, be approved by the Board.
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| (2) |
The package for every pest control product shall be sufficiently durable and be designed and manufactured to contain the pest control product safety under practical conditions of storage, display and distribution.
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| (3) |
Every package shall be designed and manufactured to permit—
| (a) |
the withdrawal of any or all of the contents in a manner that is safe to the user; and
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| (b) |
the closing of the package in a manner that will contain the pest control product satisfactorily under practical conditions.
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| (4) |
Every package shall be constructed in such a manner as to minimize the degradation or change of its contents resulting from interaction or from the effects of radiation or other means.
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| 14. |
General prohibitions
| (1) |
A label shall not contain any information respecting any organism or causative agent of a disease that is required to be reported under the Animal Diseases Act (Cap. 364).
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| (2) |
Information that is required under these Regulations to be shown on a label shall not appear at the bottom of the package.
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| (3) |
Words stating, implying or inferring that a pest control product is approved, accepted or recommended by the government or by any department or agency thereof shall not appear on a package or label or in any advertisement respecting a pest control product.
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FIRST SCHEDULE
[Regulation 3(2), L.N. 127/2006, ss. 4, 5 and 6.]
CLASSIFICATION OF PEST CONTROL PRODUCTS
| 1. |
Restricted Class
Where the Board has set forth additional essential conditions to be shown on the label respecting the display, distribution, use, limitations or qualifications of persons who may use the pest control product, the pest control product shall have the following properties—
| (a) |
acute oral LD50 is greater than 50 mg/kg body weight;
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| (b) |
acute dermal LD50 is greater than 100 mg/kg body weight;
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| (c) |
environmental risks are significant and will be judged accordingly;
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| (d) |
pest control products used in aquatic and forestry situations are classified restricted.
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[L.N. 127/2006, rr. 4 and 5.]
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| 2. |
Commercial and Agricultural Class
Where the pest control product is to be displayed and distributed for general use in commercial activities specified on the label it shall have the following properties—
| (a) |
acute oral LD50 is greater than 50 mg/kg body weight;
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| (b) |
acute dermal LD50 is greater than 100 mg/kg body weight;
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| (c) |
environmental effects possible in limited regions.
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| 3. |
Domestic Class
Where the pest control product is to be displayed and distributed for the use in and around a dwelling it shall have the following properties—
| (a) |
acute oral LD50 is over 500 mg/kg body weight;
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| (b) |
acute dermal LD50 is over 1,000 mg/kg body weight;
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| (c) |
no special precautions or equipment required for inhalation hazard;
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| (d) |
no irreversible effects from repeated exposures;
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| (e) |
disposal of product and containers can safely be done by placing in garbage;
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| (f) |
package sizes limited to amounts that can be safely used and stored by consumers.
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SECOND SCHEDULE
CAUTIONARY SYMBOLS AND WORDS
THE PEST CONTROL PRODUCTS (REGISTRATION) REGULATIONS, 1984
| 1. |
Citation
These Regulations may be cited as the Pest Control Products (Registration) Regulations, 1984.
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| 2. |
Interpretation
In these Regulations, unless the context otherwise requires—
“accredited scientists/institution” means a person or an institution that has been officially recognized by the Board as having the capacity and competence to undertake biological efficacy trials;
“active ingredient” means an ingredient of a pest control product to which the effects of the pest control product are attributed and includes a synergist; but does not include a component that by itself is not primarily responsible for the control effect of the pest control product;
“biochemical pesticide” means a pest control product whose active ingredient constitutes a chemical derived from naturally occurring plant or animal intended to control invertebrate pests;
“certificate of registration” means a certificate issued by the Board under regulation 7;
“device” means any article, instrument, apparatus, contrivance or gadget that by itself or in conjunction with a pest control product is used as a means to control pests directly or indirectly;
“experimental permit” means a permit issued by the Board for small quantity of a pest control product imported or produced locally for purposes of research and efficacy trials prior to consideration for registration;
“microbial and macrobial biopesticide” means a pest control product of naturally occurring micro-organisms (microbiological agents viruses and rickettsia; bacteria, protozoa, fungi,) and macro-organisms (macro biological agents such as predators, parasitoids and entomopathogenic nematodes), respectively intended for the control of invertebrate pests weeds, pathogens of crops, and pests of livestock and public health and to which effects of the pest control products or active agent are attributed but does not include a component that by itself is not primarily responsible for the control effect of the pest control product or genetically modified living microorganism and macro-organism;
“national collection number” means the unique code given to a culture or an isolate by the National Museums of Kenya;
“parallel/daughter registration” means a registration of a trade name based on the strength of an existing fully registered product from the same manufacturer and source and with authorization from the registrant;
“residue” means the ingredient of a pest control product that remains after the pest control product has been used and includes substances resulting from degradation or metabolism.
[L.N. 123/2006, r. 2, L.N. 124/2015, r. 2.]
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| 3. |
Exemption from registration
A pest control product shall be exempt from registration if—
| (a) |
it is for use by a person for research purposes if that use has been approved by the Board;
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| (b) |
it is a type or kind set out in the First Schedule and meets the conditions relevant to that substance as set out in that Schedule.
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| 3A. |
Efficacy testing
| (1) |
Every person desiring to introduce a pest control product for efficacy testing shall—
| (a) |
make application to the Board for an experimental permit in Form C set out in the Second Schedule;
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| (b) |
provide all the details required in the form;
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| (c) |
on request supply any further information which may be required by the Board; and
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| (d) |
pay the prescribed application fees determined by the Board from time to time therefor.
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| (2) |
| (a) |
The Board shall evaluate the data provided and if satisfied that the application merits approval, shall issue an experimental permit in the prescribed Form D in the Second Schedule
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| (b) |
The Board shall, in addition, give the applicant information relating to the existing accredited scientists or institutions in the field of trial whom the applicant will work with;
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| (3) |
When the efficacy trials are complete the accredited scientist or institution shall submit efficacy reports to the Board.
[L.N. 123/2006, r. 3.]
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| 4. |
Application for registration of pest control products
| (1) |
Every person desiring to register a pest control product shall make application to the Board in either Forms A, A1, A2, A3, A3a, A3b, A4 or A5 set out in the Second Schedule and shall, on request, supply any further information which may be required by the Board.
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| (2) |
An applicant who is not resident in Kenya shall appoint an agent permanently resident in Kenya to whom any notice or correspondence may be sent.
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| (2A) |
An application for registration of an agent shall be submitted in Form A6 set out in the Second Schedule.
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| (2B) |
An application for registration for change of an agency shall be submitted in Form A7 set out in the Second Schedule.
|
| (3) |
An application for the registration of a pest control product shall be accompanied by five copies of the proposed label for the pest control product or reasonable facsimiles thereof.
|
| (4) |
An applicant who is not resident in Kenya shall be required to deposit with the Board a binding agreement entered with the agent permanently resident in Kenya.
[L.N. 123/2006, r. 4, 5, 6, L.N. 124/2015, r. 3.]
|
|
| 4A. |
Application for registration of a synthetic or conventional pest control product
| (1) |
The application for registration of a synthetic or conventional pest control product (non-generic) under regulation 4 (1) shall be in the prescribed Form A set out in the Second Schedule completed by the applicant or duly authorized person and submitted in triplicate.
|
| (2) |
The application for registration of generic conventional pest control products shall be submitted in Form A4.
|
| (3) |
The Board shall supply the applicant with checklists and an index to ensure that the applicant has supplied the relevant data required in Form A set out in the Second Schedule.
[L.N. 124/2015, r. 4.]
|
|
| 4B. |
Application for the registration of microbial biopesticide
| (1) |
An application for the registration of microbial biopesticide shall be in Form A1 set out in the Second Schedule.
|
| (2) |
Information in support of a request for registration, both published and unpublished (fully cited), shall be supplied in the form of a summary data sheet laid out in the format given in Form A1 set out in the Second Schedule.
|
| (3) |
Pre-registration consultations between the applicant and the Board shall be undertaken after the application is made.
|
| (4) |
All applicants intending to import or export live organisms into or out of the country shall comply with all other existing laws governing such organisms.
|
| (5) |
The use of genetically modified organisms as microbial biopesticides shall comply with any other existing laws governing such organisms before an application is made to the Board.
|
| (6) |
The Board shall supply checklists and an index to ensure that the applicant has provided all relevant data and cited material.
[L.N. 124/2015, r. 5.]
|
|
| 4C. |
Application for the registration of macrobial biopesticide
| (1) |
An application for the registration of macrobial biopesticide shall be as set out in Form A2 in the Second Schedule.
|
| (2) |
Information in support of a request for registration, both published and unpublished (fully cited), shall be supplied in the form of a summary data sheet laid out in the format given in Form A2 set out in the Second Schedule.
|
| (3) |
Pre-registration consultations between the applicant and the Board shall be undertaken after the application is made.
|
| (4) |
The applicant shall be required to-
| (a) |
submit a sample of the pest control product to the National Museums of Kenya or the national collection number obtained if the culture is already in collection;
|
| (b) |
provide a sample of the technical grade of its active agent;
|
| (c) |
send an additional sample to the National Agricultural Research Laboratories, Biological Control Unit, Kenya Agricultural Research Institute and Kenya Plant Health Inspectorate Service;
|
| (d) |
supply any other sample as may be requested by the Board.
|
|
| (5) |
All applicants intending to import or export live organisms into or out of the country shall comply with any other existing laws governing such organisms.
|
| (6) |
The use of genetically modified organisms and living modified organisms as macrobial biopesticides shall comply with any other existing laws governing such organisms before an application is made to the Board.
|
| (7) |
The Board shall supply checklists and an index to ensure that the applicant has provided all relevant data and cited material.
[L.N. 124/2015, r. 6.]
|
|
| 4D. |
Application form for the registration of a biochemical pesticide other than semiochemicals
| (1) |
The application form for the registration of a biochemical pesticide other than semiochemicals, shall be in Form A3 in the Second Schedule.
|
| (2) |
Information in support of a request for registration both published and unpublished shall be supplied in form of a summary data sheet laid out according to the format given in Form A3.
|
| (3) |
Pre-registration consultation between the applicant and the registration authority shall be undertaken.
|
| (4) |
The application for registration of semiochemicals pest control products for monitoring and control of pests in crops, livestock and public health shall be in Form A3a.
|
| (5) |
The application for introduction of straight chained lepidopteran pheromone for monitoring purposes shall be in Form A3b.
[L.N. 124/2015, r. 7.]
|
|
| 4E. |
Application form for registration of spray adjuvants
| (1) |
The application form for registration of spray adjuvants shall be in Form A5 as set out in the Second Schedule.
|
| (2) |
Information in support of a request for registration, both published and unpublished (fully cited) shall be supplied in the form of a summary data sheet laid out in Form A5 in the Second Schedule.
|
| (3) |
The Board shall supply checklists and an index to ensure that the applicant has provided all relevant data and cited material.
[L.N. 124/2015, r. 8.]
|
|
| 4F. |
Registration of a parallel/daughter pest control product
| (1) |
The Board may upon such terms and conditions as it may specify, on payment of the introductory and registration fees, register a parallel/daughter pest control product where the applicant-
| (a) |
completes Form C set out in the Second Schedule;
|
| (b) |
provides a letter of access from registrant and a letter of no objection from the local agent;
|
| (c) |
submits a letter of no objection from the trade name owner where the trade name owner is not the registrant;
|
| (d) |
borrows approved label of the original registered product and only changes the trade name.
|
|
| (2) |
Each parallel/daughter registration shall have its own registration number which shall be linked to the original registered product by indicating the original registered product number on the parallel registration certificates.
|
| (3) |
Voluntary cancellation of a product shall apply to the registered product and the parallel/daughter products.
|
| (4) |
A company may leave an area without canceling the parallel/daughter registration and may transfer access of the original dossier thereto.
|
| (5) |
The parallel/daughter registration shall be automatically revoked when the registrant withdraws the letter of access.
|
| (6) |
The paralle/daughter registration shall not be used to register other different products.
|
| (7) |
A new dossier shall not be required for the registration of the parallel/daughter products;
|
| (8) |
The original registered product and the paralle/daughter registration shall be required to originate from the same source.
|
| (9) |
Parallel/daughters registrations shall be exempt from local efficacy trials if the intended use is identical to that of the original registered product.
|
| (10) |
Efficacy trials shall be undertaken where new uses which are different from those of the original registered products.
|
| (11) |
The Board shall exercise discretion in determining the number of parallel/daughter products to be registered on a case-by-case basis but not more than five such products shall be registered in respect of one original product.
[L.N. 124/2015, r. 8.]
|
|
| 4G. |
Extension of the use of a registered pest control product
The Board may, upon such terms and conditions as it may specify, extend the use of a registered pest control product through a label extension where the applicant submits-
| (a) |
successful two-season efficacy trial data on the respective area of use such as crop or pest combination;
|
| (b) |
residue data based on the Good Agriculture Practice in the efficacy trial, if the new use is on edible crops or animals;
|
| (c) |
a copy of the previously approved label;
|
| (d) |
revised commercial label with the proposed new uses, rates, pre-harvest interval and re-entry interval and the final commercial version label;
|
| (e) |
proposed maximum residue limits and pre-harvest intervals for edible commodities, withdrawal period for livestock and re-entry interval for greenhouse use.
|
|
| 4H. |
Summary dossier
The application for registration of pest control products shall be accompanied by a copy of a summary dossier as prescribed in form-
| (a) |
B for conventional pest control products;
|
| (b) |
B1 for microbial pest control products;
|
| (c) |
B2 for macrobial pest control products;
|
| (d) |
B3 for biochemical pest control products other than semiochemicals; and
|
|
| 5. |
Applicant to provide samples
| (1) |
An applicant shall, when requested to do so by the Board, provide—
| (a) |
a sample of the pest control product;
|
| (b) |
a sample of the technical grade of its active ingredient;
|
| (c) |
a sample of the laboratory standard of its active ingredient; and
|
| (d) |
any other sample as may be required by the Board.
|
|
| (2) |
The samples shall be submitted to the Board in Form A8 set out in the Second Schedule.
[L.N. 124/2015, r. 9.]
|
|
| 6. |
Registration fees
The fees payable by an applicant for the registration of a pest control product shall be the prescribed fees determined by the Board from time to time where a pest control product is a device or it contains an active ingredient that has been previously assessed or evaluated for the purpose of the Act and these Regulations.
|
| 7. |
Issue of certificate of registration
| (1) |
The Board shall consider the application under regulation 4, and, if it is satisfied of the safety, efficacy, quality and economic value of the pest control product, shall register the pest control product, and issue a certificate of registration which shall be in Form B set out in the Second Schedule.
|
| (1A) |
The applicant shall submit the proposed trade name for consideration by the Board.
|
| (1B) |
The trade name in sub-regulation (1A) may be changed upon request to the Board in Form A9 set out in the Second Schedule.
|
| (1C) |
The fees payable by an applicant for the change of a trade name of a pest control product shall be ten thousand shillings.
|
| (2) |
If the Board is not satisfied as to the safety, efficacy, quality and economic value of the pest control product it may, after providing an opportunity for the applicant to be heard, reject the application for the registration of the pest control product and inform the applicant the reasons for the rejection in writing.
|
| (3) |
No person to whom a certificate of registration has been issued under this Regulation shall lend, hire, sell, transfer or otherwise dispose of the certificate to any other person without the approval of the Board, which approval shall be endorsed on the certificate of registration.
[L.N. 124/2015, r. 10.]
|
| (1) |
Any person who intends to handle, use, distribute, transport or deal in a Pest Control Product under restricted class shall apply to the Board for a permit in the prescribed Form D in the Schedule.
|
| (2) |
No person shall handle, use, distribute, transport or deal in a Pest Control Product under restricted class without a permit from the Board in the prescribed Form E in the Schedule.
[LN 124 of 20006, s. 7.]
|
|
| 9. |
Temporary registration
| (1) |
The Board may upon such terms and conditions as it may specify, on payment of a prescribed fee determined by the Board from time to time, register a pest control product for a period not exceeding one year where—
|
| (2) |
Any terms and conditions specified by the Board under paragraph (1) shall be contained in the temporary certificate of registration.
|
|
| 10. |
Refusal to register pest control
The Board may refuse to register a pest control product if in its opinion—
| (a) |
the applicant for registration or the label for the pest control product does not comply with, the provisions of the Act and these Regulation;
|
| (b) |
the information provided to the Board by the applicant is insufficient to enable the pest control product to be assessed or evaluated;
|
| (c) |
the applicant fails to establish that the pest control product has merit or value for the purpose claimed when the pest control product is used in accordance with its label directions; or
|
| (d) |
the use of the pest control product would lead to an unacceptable risk or harm to—
| (i) |
things on or in relation to which the pest control product in intended to be used; or |
| (ii) |
public health, plants, animals or the environment. |
|
|
| 11. |
Suspension and revocation of certificates of registration
| (1) |
The Board may suspend, amend or revoke a certificate of registration issued under these Regulations for such time as the Board may determine.
|
| (2) |
The powers conferred by paragraph (1) shall not be exercised by the Board except on one or more of the following grounds—
| (a) |
that the matters stated in the application on which the certificate of registration was granted were false or incomplete in a material particular;
|
| (b) |
that new information has become available to the Board which renders the pest control product unsafe or dangerous;
|
| (c) |
that the premises on which, or on part of which, the pest control product is manufactured, assembled or stored by or on behalf of the holder of the certificate of registration are unsuitable for the manufacturing, assembly or storage of pest control products;
|
| (d) |
that the holder of a certificate of registration has given a notice to the Board in writing of any intentions to suspend product registration for a period not exceeding 5 years;
|
| (e) |
that new information has become available to the Board indicating that the pest control product is sourced from a manufacturer, formulator, repacker or any facility other than that specified in the application forms and dossier for registration for the respective pest control product or sources authorized by the Board;
|
| (f) |
that the principal or registrant withdraws the technical support to the local agent or distributor on the basis of which a pest control product was registered, in writing;
|
| (g) |
that the new information has become available to the Board which renders the pest control product ineffective, not efficacious or of no economic value for the purposes for which it is intended;
|
| (h) |
that a holder of a registered pest control product has in connection with the registration concerned, contravened or failed to comply with a provision of this Act;
|
| (i) |
that a holder of such registration has contravened or failed to comply with a condition to which the registration concerned is subject to;
|
| (j) |
that it is contrary to the public interest that such pest control product should remain registered;
|
| (k) |
that any incorrect or misleading advertisement is used in connection with any registered pest control product.
|
|
|
| 12. |
Notice to holder of certificate of registration, etc.
| (a) |
refuses to register a pest control products; or
|
| (b) |
suspends or revokes the certificate of registration, it shall send to the applicant or the holder of a certificate of registration, as the case may be, a notice by registered post notifying him of the refusal, suspension or revocation.
|
|
| 13. |
Appeals
| (1) |
An applicant or holder of a certificate of registration who has received a notice under regulation 12 may within thirty days from the date which the notice is received by him appeal to the Minister, who may amend or vary the decision as he thinks fit and whose decision shall be final.
|
|
| 14. |
Records
A holder of a certificate of registration issued under these Regulations shall keep a record of all the quantities of pest control products stored, manufactured or sold by him and the record shall—
| (a) |
be maintained for five years from the time it is made; and
|
| (b) |
be made available to the Board at such times and in much manner as the Board may require.
|
|
| 15. |
Declared source of product
| (1) |
Where a certificate of registration is issued under this regulation, the product shall be obtained from the declared source at the time of registration.
|
| (2) |
An application for change of source for the product shall be submitted to the Board as prescribed in Form E set out in the Second Schedule.
[L.N.124/2015, r. 11.]
|
|
FIRST SCHEDULE
ITEMS EXEMPTED FROM REGISTRATION
| 1. |
Garment bags, cabinets or chests that are manufactured, represented or sold as a means to protect clothing or fabrics from pests.
|
| 2. |
Electronic apparatus that is manufactured, represented or sold as a means to attract or destroy flying insects.
|
| 3. |
Devices of products that are manufactured, represented or sold to repel birds and other pests by causing physical discomfort by means of sound or touch
|
| 4. |
Devices of attachment to garden watering hoses that are manufactured, represented or sold as pest control product.
|
| 5. |
Devices that are manufactured, represented or sold as a means of providing the automatic or unattended application of a pest control product.
|
| 6 |
Devices that are sold for use with chemical products containing cyanide as a means to control animal pests.
|
THE PEST CONTROL PRODUCTS (LABELLING, ADVERTISING AND PACKAGING) REGULATIONS, 1984
ARRANGEMENT OF REGULATIONS
3. LABELLING REQUIREMENTS
| 5. |
Notice on display panel
|
| 6. |
Display of additional information
|
| 7. |
Information where product is distributed in bulk
|
SCHEDULES
THE PEST CONTROL PRODUCTS (IMPORTATION AND EXPORTATION) REGULATIONS, 1984
| 1. |
Citation
These Regulations may be cited as the Pest Control Products (Importation and Exportation) Regulations, 1984.
|
| 2. |
Importation and exportation prohibited unless licensed
| (1) |
No person shall import or export a pest control product for commercial purposes unless that person is in possession of a licence issued under these Regulations.
|
| (2) |
No licence shall be issued for the importation of a pest control product unless the pest control product is registered in accordance with the Pest Control Products (Registration) Regulations, 1984.
|
| (3) |
No licence shall be issued under these Regulations unless the Board is satisfied that the provisions of the Pest Control Products Act, 1982 have been complied with.
|
|
| 3. |
Presumptions
| (1) |
For the purpose of paragraph (1) of regulation 2, a pest control product shall be considered to be for commercial purposes if it is for a use other than scientific research or testing and products imported for resale, manufacture, formulation, owner’s use or commodity aid shall be deemed to be imported for commercial purposes.
|
| (2) |
For the purpose of paragraph (1) of regulation 2, a pest control product shall be deemed to have been exported when it is placed on any ship, aircraft, train or vehicle within Kenya for the purpose of export.
|
|
| 4. |
Application for licences
| (1) |
Any person desiring a licence in respect of importation or exportation of a pest control product for commercial purposes shall apply to the Board for a licence in Form PCPB 1 set out in the Schedule which form shall be signed by the importer or exporter, as the case may be, who shall state the purpose of the importation or exportation of the pest control product in the following manner—
| (i) |
"FOR RESALE", where the product is being imported or exported for the purpose of resale whether in the original pack or after repacking; or |
| (ii) |
"FOR MANUFACTURING PURPOSES", where the pest control product is being imported or exported for use in the manufacture or formulation of a registered pest control product; or |
| (iii) |
"FOR IMPORTER’S OWN USE", where the pest control product is being imported into Kenya or exported to another country for the sole use of the importer, together with information respecting where the pest control product shall be used and the nature of that use. |
|
| (2) |
The Board shall from time to time determine the fee to be paid in respect of an application for a licence.
|
|
| 5. |
Dealing with applications and issue of licences, etc.
| (1) |
The Board may approve an application made under regulation 4 if it is satisfied that—
| (a) |
the application contains the information required under that regulation;
|
| (b) |
the pest control product contains ingredients that have been previously assessed or evaluated for the purposes of the Act and these Regulations and which have been accepted for registration under the Pest Control Products (Registration) Regulations, 1984, for the use stated in the application;
|
| (c) |
premises where the pest control product is to be stored, processed, warehoused, used, repacked or sold shall have been duly licensed by the Board,
|
and issue a licence in Form PCPB 1 set out in the Schedule.
|
| (2) |
Where the Board does not approve an application it shall not be obliged to give any reason therefor.
|
| (3) |
No person to whom a licence has been issued under these Regulations shall lend, hire, sell, transfer or otherwise dispose of that licence to any other person without the approval of the Board, which approval shall be endorsed on the licence.
|
| (4) |
The Board may attach to a licence such conditions as it deems fit to impose and in particular any such condition may restrict the importation and exportation of a pest control product from a specified source or for specified usage and the Board may, from time to time, vary, add to or revoke any of the conditions attached to a licence.
|
| (5) |
The licence issued under regulation 2(1) shall be valid for three (3) months from the date of issue.
[L.N. 125/2006, r. 2.]
|
|
| 6. |
Duty of licensees, etc.
| (1) |
Repealed by L.N. 125/2006, r. 3.
|
| (2) |
It shall be the sole responsibility of the importer or his agent to ensure that Form PCPB 1 is endorsed by the Customs Department at the port of entry and to forward a signed copy to the Board
[L.N. 125/2006, r. 3.]
|
|
| 7. |
Duty of customs officers
Where for any reason a customs officer at a port of entry withholds the release of any pest control product he shall forthwith advise the Board of that action.
|
| 8. |
Cancellation and suspension of licences
| (1) |
The Board may cancel or, for such period as it thinks fit, suspend a licence issued under these Regulations if the Board is satisfied that—
| (a) |
the licensee or his servant or agent has been convicted of an offence under the Act; or
|
| (b) |
the licensee or his servant or agent has committed a breach of any of the terms or conditions of the licence; or
|
| (c) |
for any other reason, it is in the public interest so to do.
|
|
| (2) |
Before cancelling or suspending a licence under this Regulation the Board shall give the licensee twenty-eight days’ notice to show cause why the licence should not be cancelled or suspended and the Board’s decision in the matter shall be final.
|
|
| 9. |
Imported pest control products to comply with these Regulations
No person shall package, store, transport, display, distribute, sell or otherwise deal in a pest control product that has not been imported in accordance with these Regulations.
[L.N. 125/2006, r. 4.]
|
| 10. |
Licence prescribed form
A licence to import or export a pest control product under these Regulations shall be in the prescribed Form PCPB2 set out in the Schedule.
[L.N. 125/2006, r. 5.]
|
THE PEST CONTROL PRODUCTS (LABELLING, ADVERTISING AND PACKAGING) REGULATIONS, 1984
| 1. |
Citation
These Regulations may be cited as the Pest Control Products (Labelling, Advertising and Packaging) Regulations, 1984.
|
| 2. |
Interpretation
In these Regulations, unless the context otherwise requires—
"display panel" means part of a label applied on or affixed to the package of a pest control product but does not include a leaflet or brochure unless it is part of the label;
"Formulator" means a person who prepares the active ingredient of a pest control product into a form which is convenient for its intended use;
"Re-packer" means a person who puts a formulated product into appropriate unit sizes.
[L.N. 127/2006, r. 2.]
|
| 3. |
Labelling requirements
| (1) |
No pest control product shall be distributed or sold without a label.
|
| (2) |
No label shall be used on a pest control product unless it has been approved by the Board and, unless the Board otherwise directs, every label shall show—
| (a) |
the name of a pest control product which shall be descriptive of the physical form and the purpose of the pest control product and shall include the common name of its active ingredients and may include a distinctive brand or trade mark;
|
| (b) |
the class designation of the pest control product in capital letters and shall be classified as set out in the First Schedule;
|
| (c) |
information detailing the nature and degree of hazard inherent in the pest control product and the nature and degree of hazard shall be identified by the appropriate precautionary symbol and signal words selected from the Second Schedule together with a statement respecting the nature of the primary hazard to which the symbol relates;
|
| (d) |
a statement directing the user to read the label which statement shall be in the following form – "READ THE LABEL BEFORE USING";
|
| (e) |
a guarantee statement in the following manner—
| (i) |
the word in capital letters "GUARANTEE", followed by; |
| (ii) |
a colon; followed by; |
| (iii) |
the common name of the active ingredient of pest control product or where a common name has not been designated, the chemical or other name of the active ingredient; followed by; |
| (iv) |
the contents of the active ingredient expressed— |
|
| (f) |
the registration number of the pest control product which shall be set out in the following manner—
"REGISTRATION NO. PCPB (CR) 0000" AND PCPB (TCR) 0000";
Where "CR" means Certificate of Registration for a period of three years and or renewal for a period not exceeding two years at any one time; and "TCR" means Temporary Certificate of Registration for a period not exceeding one year;
|
| (g) |
a statement of the net contents of the package for the pest control product, which shall be expressed—
| (i) |
in the case of a liquid pest control product of a volume less than one litre, in terms of millilitres; |
| (ii) |
in the case of a liquid pest control product of a volume of one litre or more, in terms of litres; |
| (iii) |
in the case of a pressure-packed pest control product in terms of weight, in grams if less than one kilogram; |
| (iv) |
in the case of a pressure-packed pest control product which weighs one kilogram or more, in terms of kilograms; |
| (v) |
in the case of a dry formulation pest control product which weighs less than a kilogram, in terms of grams; |
| (vi) |
in the case of a dry formulation pest control product which weighs one kilogram or more, in terms of kilograms; |
| (vii) |
in the case of a pest control product that is semi-solid or viscous in terms of either weight or volume in accordance with this paragraph; or |
| (viii) |
in the case of a pest control product the nature of which does not lend itself to net content statements prescribed in this paragraph, in terms acceptable to the Board; |
|
| (h) |
the name and postal address of the registrant and the name and postal address of the resident agent, if any and the names and postal addresses of manufacturer, formulator, distributor and re-packer;
|
| (i) |
the directions for use of the pest control product, which directions shall include dosage rates, timing of application and use limitations;
|
| (j) |
information identifying any significant hazards respecting the handling, storage, display, distribution and disposal of the pest control product which information shall include instructions respecting procedures to alleviate the hazard and when required by the Board, instructions respecting decontamination procedures and disposal of the pest control product and the empty package;
|
| (k) |
information identifying any significant hazard to—
| (i) |
things on or in relation to which the pest control product is intended to be used; or |
| (ii) |
public health, plants, animals or the environment, which information shall include instructions respecting the procedures to alleviate any such hazard; |
|
| (l) |
instructions for first aid, which instructions shall be under the heading in capital letters "FIRST AID INSTRUCTIONS" and shall set out the practical measures to be taken in the event of poisoning or other injury caused by the pest control product;
|
| (m) |
the toxicological information essential to the treatment of a person poisoned or otherwise injured by the pest control product, which information shall be under the heading in capital letters "TOXICOLOGICAL INFORMATION" and shall—
| (i) |
describe the symptoms of poisoning; |
| (ii) |
state antidotes and remedial measures; and |
| (iii) |
state the ingredient that may affect the treatment; |
|
| (n) |
a notice to the user of the pest control product which notice shall be in the following manner;
|
|
This pest control product is to be used only in accordance with the directions on this label. It is an offence under the Pest Control Products Act (Cap. 346) to use or store a pest control product under unsafe conditions;
| (o) |
the colour codes banding precautionary pictograms relating to the toxicity of the product in the following manner of declining toxicity—
| (i) |
PMS Red 199C for products classified under WHO class Ia and Ib; |
| (ii) |
PMS yellow C for products classified under WHO class II; |
| (iii) |
PMS Blue 293C for products classified under WHO class III; |
| (iv) |
PMS Green 347C for unclassified products under WHO classification; |
| (v) |
the colour shall not be used elsewhere on the label; and |
| (vi) |
any other pictogram as directed by the Board; |
|
| (p) |
separate pictograms depicting at least one pest controlled by the pest control product and crop or animal or other usage as registered under this Act;
|
| (q) |
an instruction directing the user on storage which shall be in capital letters– KEEP LOCKED OUT OF REACH OF CHILDREN;
|
| (r) |
information on the date of manufacture, expiry date, batch number and shelf-life if stored in original container under cool dry conditions.
|
| (3) |
The label for a pest control product which is a device of a type or kind listed in the First Schedule to the Pest Control Products (Registration) Regulations shall contain the information referred to in subparagraphs (f), (h), (i), (j), and (k) of paragraph (2).
[L.N. 127/2006, r. 3.]
|
|
| 4. |
Display panels
| (1) |
The display panel shall consist of one principal display panel and at least one secondary display panel.
|
| (2) |
Where the primary purpose of a pest control product is not to control, prevent, destroy, mitigate, attract or repel a pest, but it has these properties, the pest control product shall have a display panel with—
| (a) |
the information referred to in subparagraphs (a), (b), (c), (d), (g) and (h) of regulation 3(2) on the principal display panel; and
|
| (b) |
the information referred to in subparagraphs (e), (f), (i), (l) and (m) of regulation 3(2) on the secondary display panel.
|
|
| (3) |
Where the primary purpose of a pest control product is to control, prevent, destroy, mitigate, attract or repel a pest, the pest control product shall have a display panel with the information referred to in subparagraphs (a), (b), (c), (d), (e), (f), (g) and (h) of regulation 3(2) on the principal display panel.
|
| (4) |
This Regulation shall apply to a label for a pest control product that is within the meaning of paragraph (a) of the definition of "pest control product" in section 2 of the Act.
|
|
| 5. |
Notice on display panel
| (1) |
Where the principal display panel shows the pest control product as "RESTRICTED", the notice referred to in regulation 3(2)(n) shall appear prominently at the top of the secondary display panel followed by the heading in capital letters "RESTRICTED USE", followed by the directions for use, dosage, timing of application and use limitations to which the restrictions relates all of which shall be circumscribed by a line to set the information apart from all other information required to be shown on the secondary display panel.
|
| (2) |
Notwithstanding paragraph (1), where the principle display panel shows the pest control product as "RESTRICTED" the directions for use, dosage rates, timing of application and use limitations to which the restriction relates, together with the information referred to in subparagraphs (a), (b), (c), (d), (e), (f), (g), (h) and (i) of regulation 3(2) may, with the approval of the Board, appear in a brochure or leaflet that will accompany the package for the pest control product.
|
| (3) |
Where the information required to be shown on the label is not included in the display panel, the display panel shall contain the words in capital letters "READ ATTACHED BROCHURE BEFORE USE" prominently displayed thereon.
|
|
| 6. |
Display of additional information
| (1) |
Subject to the approval of the Board, additional information relating to the pest control product and any graphic design or symbol maybe shown on the label if it does not unreasonably detract or obscure the information required to be shown on the label under these Regulations.
|
| (2) |
A registrant may include on the label the following liability limitation warranty—
Seller’s guarantee is limited to the terms set out on the label and subject thereto, the buyer assumes the risk to persons or property arising from the use or handling of this product and accepts the product on that condition.
|
|
| 7. |
Information where product is distributed in bulk
Where a pest control product is distributed in a bulk container, the information referred to in subparagraphs (a), (b), (e), (f), (g), (h), (i) and (m) of regulation 3(2) shall be shown—
| (a) |
on the bulk container; and
|
| (b) |
on the documents respecting the pest control product or on a statement accompanying the consignment.
|
|
| 8. |
Information on label
| (1) |
The information on every label shall be printed in both English and Kiswahili languages.
|
| (2) |
All units of measures shown on the label shall be expressed in accordance with the requirements of the Weights and Measures Act (Cap. 513).
|
| (3) |
All information shown on the label shall be printed in a manner that is conspicuous, legible and indelible.
|
|
| 9. |
Denaturation
Where the physical properties of a pest control product are such that the presence of the pest control product may not be recognized when it is used, and is likely to expose a person or domestic animal to a severe health risk, the pest control product shall be denatured by means of colour, odour or such other means as the Board may approve to provide signal or warning of its presence.
|
| 10. |
Storage and display
A pest control product shall be stored and displayed in accordance with the conditions shown on the label.
|
| 11. |
Distribution
Notwithstanding the provisions of the Pharmacy and Poisons Act (Cap. 244), a pest control product shall be distributed in accordance with such condition as the Board shall specify.
|
| 12. |
Prohibition
No person shall use a pest control product in a manner that is inconsistent with the directions or limitations respecting its use as shown on the label.
|
| 13. |
Packaging
| (1) |
Every package for a pest control product shall, unless the Board otherwise directs, be approved by the Board.
|
| (2) |
The package for every pest control product shall be sufficiently durable and be designed and manufactured to contain the pest control product safety under practical conditions of storage, display and distribution.
|
| (3) |
Every package shall be designed and manufactured to permit—
| (a) |
the withdrawal of any or all of the contents in a manner that is safe to the user; and
|
| (b) |
the closing of the package in a manner that will contain the pest control product satisfactorily under practical conditions.
|
|
| (4) |
Every package shall be constructed in such a manner as to minimize the degradation or change of its contents resulting from interaction or from the effects of radiation or other means.
|
|
| 14. |
General prohibitions
| (1) |
A label shall not contain any information respecting any organism or causative agent of a disease that is required to be reported under the Animal Diseases Act (Cap. 364).
|
| (2) |
Information that is required under these Regulations to be shown on a label shall not appear at the bottom of the package.
|
| (3) |
Words stating, implying or inferring that a pest control product is approved, accepted or recommended by the government or by any department or agency thereof shall not appear on a package or label or in any advertisement respecting a pest control product.
|
|
FIRST SCHEDULE
[Regulation 3(2), L.N. 127/2006, ss. 4, 5 and 6.]
CLASSIFICATION OF PEST CONTROL PRODUCTS
| 1. |
Restricted Class
Where the Board has set forth additional essential conditions to be shown on the label respecting the display, distribution, use, limitations or qualifications of persons who may use the pest control product, the pest control product shall have the following properties—
| (a) |
acute oral LD50 is greater than 50 mg/kg body weight;
|
| (b) |
acute dermal LD50 is greater than 100 mg/kg body weight;
|
| (c) |
environmental risks are significant and will be judged accordingly;
|
| (d) |
pest control products used in aquatic and forestry situations are classified restricted.
|
[L.N. 127/2006, rr. 4 and 5.]
|
| 2. |
Commercial and Agricultural Class
Where the pest control product is to be displayed and distributed for general use in commercial activities specified on the label it shall have the following properties—
| (a) |
acute oral LD50 is greater than 50 mg/kg body weight;
|
| (b) |
acute dermal LD50 is greater than 100 mg/kg body weight;
|
| (c) |
environmental effects possible in limited regions.
|
|
| 3. |
Domestic Class
Where the pest control product is to be displayed and distributed for the use in and around a dwelling it shall have the following properties—
| (a) |
acute oral LD50 is over 500 mg/kg body weight;
|
| (b) |
acute dermal LD50 is over 1,000 mg/kg body weight;
|
| (c) |
no special precautions or equipment required for inhalation hazard;
|
| (d) |
no irreversible effects from repeated exposures;
|
| (e) |
disposal of product and containers can safely be done by placing in garbage;
|
| (f) |
package sizes limited to amounts that can be safely used and stored by consumers.
|
|
SECOND SCHEDULE
CAUTIONARY SYMBOLS AND WORDS
THE PEST CONTROL PRODUCTS (IMPORTATION AND EXPORTATION) REGULATIONS, 1984
ARRANGEMENT OF REGULATIONS
| 2. |
Importation and exportation prohibited unless licensed
|
| 4. |
Application for licences
|
| 5. |
Dealing with applications and issue of licences, etc.
|
| 6. |
Duty of licensees, etc.
|
| 7. |
Duty of customs officers
|
| 8. |
Cancellation and suspension of licences
|
| 9. |
Imported pest control products to comply with these Regulations
|
| 10. |
Licence prescribed form
|
SCHEDULES
THE PEST CONTROL PRODUCTS (DISPOSAL) REGULATIONS, 2006
| 1. |
Citation
These Regulations may be cited as the Pest Control Products (Disposal) Regulations, 2006.
|
| 2. |
Disposal of pest control products for commercial purpose
| (1) |
No person shall dispose of any pest control product or their containers in a manner that shall be detrimental to man, animal and the environment.
|
| (2) |
No person shall carry out any disposal of pest control product or containers for commercial purposes unless that person or institution is in possession of a licence under these Regulations and all provisions of the Act have been complied with.
|
| (3) |
The use of any pest control product disposal method shall be approved by the Board subject to specific requirements laid down by the Board.
|
| (4) |
The transboundary movements of pesticides for disposal shall be subject to ratified conventions, protocols, treaties or agreements to which Kenya is a party.
|
| (5) |
Without prejudice to the provisions of the Environmental Management and Co-ordination Act, any person or institution desiring a licence for disposal of pest control products for commercial purposes shall apply to the Board for a licence in the prescribed Form A set out in the Schedule and shall be accompanied by the prescribed fees.
|
|
| 3. |
Application for disposal licence
| (1) |
The Board may approve an application made under Regulation 2 and shall issue a licence as set out in Form B in the Schedule if it is satisfied that:
| (a) |
the application contains the information required under these regulations;
|
| (b) |
approved methods of disposal would be used or applied;
|
| (c) |
the applicant has sufficient expertise to dispose of the pest control products in question.
|
|
| (2) |
Disposal for commercial purposes shall be supervised by the Board which shall issue a certificate of disposal in the prescribed Form C in the Schedule after successful disposal.
|
| (3) |
Where the Board does not approve an application it shall not be obliged to give any reason thereof.
|
| (4) |
The Board may attach to a licence such conditions as it deems fit.
|
| (5) |
No person or institution to which a licence has been issued under these Regulations shall lend, hire, sell, transfer or otherwise dispose of that licence to any person or institution without the approval of the Board, which approval shall be endorsed on the licence.
|
|
| 4. |
Cancellation or suspension of licence
| (1) |
The Board may cancel or suspend for a period it deems fit the licence issued under these Regulations if satisfied that-
| (a) |
the licensee, his servant or agent has been convicted of an offence under the Act; or
|
| (b) |
the licensee, his servant or agent has breached any of the terms or conditions of the licence; or
|
| (c) |
for any other reason, that it is in public interest to do so.
|
|
| (2) |
Before cancelling or suspending a licence under this regulation, the Board shall give the licensee twenty-one days' notice to show cause why the licence should not be cancelled or suspended and the Board's decision in the matter shall be final.
|
|
THE PEST CONTROL PRODUCTS (IMPORTATION AND EXPORTATION) REGULATIONS, 1984
| 1. |
Citation
These Regulations may be cited as the Pest Control Products (Importation and Exportation) Regulations, 1984.
|
| 2. |
Importation and exportation prohibited unless licensed
| (1) |
No person shall import or export a pest control product for commercial purposes unless that person is in possession of a licence issued under these Regulations.
|
| (2) |
No licence shall be issued for the importation of a pest control product unless the pest control product is registered in accordance with the Pest Control Products (Registration) Regulations, 1984.
|
| (3) |
No licence shall be issued under these Regulations unless the Board is satisfied that the provisions of the Pest Control Products Act, 1982 have been complied with.
|
|
| 3. |
Presumptions
| (1) |
For the purpose of paragraph (1) of regulation 2, a pest control product shall be considered to be for commercial purposes if it is for a use other than scientific research or testing and products imported for resale, manufacture, formulation, owner’s use or commodity aid shall be deemed to be imported for commercial purposes.
|
| (2) |
For the purpose of paragraph (1) of regulation 2, a pest control product shall be deemed to have been exported when it is placed on any ship, aircraft, train or vehicle within Kenya for the purpose of export.
|
|
| 4. |
Application for licences
| (1) |
Any person desiring a licence in respect of importation or exportation of a pest control product for commercial purposes shall apply to the Board for a licence in Form PCPB 1 set out in the Schedule which form shall be signed by the importer or exporter, as the case may be, who shall state the purpose of the importation or exportation of the pest control product in the following manner—
| (i) |
"FOR RESALE", where the product is being imported or exported for the purpose of resale whether in the original pack or after repacking; or |
| (ii) |
"FOR MANUFACTURING PURPOSES", where the pest control product is being imported or exported for use in the manufacture or formulation of a registered pest control product; or |
| (iii) |
"FOR IMPORTER’S OWN USE", where the pest control product is being imported into Kenya or exported to another country for the sole use of the importer, together with information respecting where the pest control product shall be used and the nature of that use. |
|
| (2) |
The Board shall from time to time determine the fee to be paid in respect of an application for a licence.
|
|
| 5. |
Dealing with applications and issue of licences, etc.
| (1) |
The Board may approve an application made under regulation 4 if it is satisfied that—
| (a) |
the application contains the information required under that regulation;
|
| (b) |
the pest control product contains ingredients that have been previously assessed or evaluated for the purposes of the Act and these Regulations and which have been accepted for registration under the Pest Control Products (Registration) Regulations, 1984, for the use stated in the application;
|
| (c) |
premises where the pest control product is to be stored, processed, warehoused, used, repacked or sold shall have been duly licensed by the Board,
|
and issue a licence in Form PCPB 1 set out in the Schedule.
|
| (2) |
Where the Board does not approve an application it shall not be obliged to give any reason therefor.
|
| (3) |
No person to whom a licence has been issued under these Regulations shall lend, hire, sell, transfer or otherwise dispose of that licence to any other person without the approval of the Board, which approval shall be endorsed on the licence.
|
| (4) |
The Board may attach to a licence such conditions as it deems fit to impose and in particular any such condition may restrict the importation and exportation of a pest control product from a specified source or for specified usage and the Board may, from time to time, vary, add to or revoke any of the conditions attached to a licence.
|
| (5) |
The licence issued under regulation 2(1) shall be valid for three (3) months from the date of issue.
[L.N. 125/2006, r. 2.]
|
|
| 6. |
Duty of licensees, etc.
| (1) |
Repealed by L.N. 125/2006, r. 3.
|
| (2) |
It shall be the sole responsibility of the importer or his agent to ensure that Form PCPB 1 is endorsed by the Customs Department at the port of entry and to forward a signed copy to the Board
[L.N. 125/2006, r. 3.]
|
|
| 7. |
Duty of customs officers
Where for any reason a customs officer at a port of entry withholds the release of any pest control product he shall forthwith advise the Board of that action.
|
| 8. |
Cancellation and suspension of licences
| (1) |
The Board may cancel or, for such period as it thinks fit, suspend a licence issued under these Regulations if the Board is satisfied that—
| (a) |
the licensee or his servant or agent has been convicted of an offence under the Act; or
|
| (b) |
the licensee or his servant or agent has committed a breach of any of the terms or conditions of the licence; or
|
| (c) |
for any other reason, it is in the public interest so to do.
|
|
| (2) |
Before cancelling or suspending a licence under this Regulation the Board shall give the licensee twenty-eight days’ notice to show cause why the licence should not be cancelled or suspended and the Board’s decision in the matter shall be final.
|
|
| 9. |
Imported pest control products to comply with these Regulations
No person shall package, store, transport, display, distribute, sell or otherwise deal in a pest control product that has not been imported in accordance with these Regulations.
[L.N. 125/2006, r. 4.]
|
| 10. |
Licence prescribed form
A licence to import or export a pest control product under these Regulations shall be in the prescribed Form PCPB2 set out in the Schedule.
[L.N. 125/2006, r. 5.]
|
THE PEST CONTROL PRODUCTS (DISPOSAL) REGULATIONS, 2006
ARRANGEMENT OF REGULATIONS
| 2. |
Disposal of pest control products for commercial purpose
|
| 3. |
Application for disposal licence
|
| 4. |
Cancellation or suspension of licence
|
SCHEDULES
THE PEST CONTROL PRODUCTS (LICENCE FEES AND OTHER CHARGES) REGULATIONS, 2006
| 1. |
Citation
These Regulations may be cited as the Pest Control Products (Licence Fees and Other Charges) Regulations, 2006.
|
| 2. |
Fees payable
The fees payable to the Board by any person for services rendered by the Board shall be as prescribed by the Board from time to time as set out in the Schedule and the fees chargeable shall be added in case of combination of businesses in category I in the Schedule.
|
| 3. |
Charges for supervision services
The charges for supervision services rendered by the Board shall be as prescribed by the Board from time to time as set out in the Schedule.
|
| 4. |
Import fee
The Board may charge an import fee at the rate of 0.8% free on board (F.O.B.) value of the product and shall be paid to the Board as agreed with the Agrochemicals Association of Kenya of which 0.4% shall be used by the Board to train end-users and other stake holders on safe use of products and the remaining 0.4% shall be remitted by the Board to the Association for the same purpose of training.
|
SCHEDULE
LICENSING OF PREMISES
THE PEST CONTROL PRODUCTS (DISPOSAL) REGULATIONS, 2006
| 1. |
Citation
These Regulations may be cited as the Pest Control Products (Disposal) Regulations, 2006.
|
| 2. |
Disposal of pest control products for commercial purpose
| (1) |
No person shall dispose of any pest control product or their containers in a manner that shall be detrimental to man, animal and the environment.
|
| (2) |
No person shall carry out any disposal of pest control product or containers for commercial purposes unless that person or institution is in possession of a licence under these Regulations and all provisions of the Act have been complied with.
|
| (3) |
The use of any pest control product disposal method shall be approved by the Board subject to specific requirements laid down by the Board.
|
| (4) |
The transboundary movements of pesticides for disposal shall be subject to ratified conventions, protocols, treaties or agreements to which Kenya is a party.
|
| (5) |
Without prejudice to the provisions of the Environmental Management and Co-ordination Act, any person or institution desiring a licence for disposal of pest control products for commercial purposes shall apply to the Board for a licence in the prescribed Form A set out in the Schedule and shall be accompanied by the prescribed fees.
|
|
| 3. |
Application for disposal licence
| (1) |
The Board may approve an application made under Regulation 2 and shall issue a licence as set out in Form B in the Schedule if it is satisfied that:
| (a) |
the application contains the information required under these regulations;
|
| (b) |
approved methods of disposal would be used or applied;
|
| (c) |
the applicant has sufficient expertise to dispose of the pest control products in question.
|
|
| (2) |
Disposal for commercial purposes shall be supervised by the Board which shall issue a certificate of disposal in the prescribed Form C in the Schedule after successful disposal.
|
| (3) |
Where the Board does not approve an application it shall not be obliged to give any reason thereof.
|
| (4) |
The Board may attach to a licence such conditions as it deems fit.
|
| (5) |
No person or institution to which a licence has been issued under these Regulations shall lend, hire, sell, transfer or otherwise dispose of that licence to any person or institution without the approval of the Board, which approval shall be endorsed on the licence.
|
|
| 4. |
Cancellation or suspension of licence
| (1) |
The Board may cancel or suspend for a period it deems fit the licence issued under these Regulations if satisfied that-
| (a) |
the licensee, his servant or agent has been convicted of an offence under the Act; or
|
| (b) |
the licensee, his servant or agent has breached any of the terms or conditions of the licence; or
|
| (c) |
for any other reason, that it is in public interest to do so.
|
|
| (2) |
Before cancelling or suspending a licence under this regulation, the Board shall give the licensee twenty-one days' notice to show cause why the licence should not be cancelled or suspended and the Board's decision in the matter shall be final.
|
|
THE PEST CONTROL PRODUCTS (LICENCE FEES AND OTHER CHARGES) REGULATIONS, 2006
ARRANGEMENT OF REGULATIONS
| 3. |
Charges for supervision services
|
SCHEDULES
| SCHEDULE — |
LICENSING OF PREMISES
|
THE PEST CONTROL PRODUCTS (LICENCE FEES AND OTHER CHARGES) REGULATIONS, 2006
| 1. |
Citation
These Regulations may be cited as the Pest Control Products (Licence Fees and Other Charges) Regulations, 2006.
|
| 2. |
Fees payable
The fees payable to the Board by any person for services rendered by the Board shall be as prescribed by the Board from time to time as set out in the Schedule and the fees chargeable shall be added in case of combination of businesses in category I in the Schedule.
|
| 3. |
Charges for supervision services
The charges for supervision services rendered by the Board shall be as prescribed by the Board from time to time as set out in the Schedule.
|
| 4. |
Import fee
The Board may charge an import fee at the rate of 0.8% free on board (F.O.B.) value of the product and shall be paid to the Board as agreed with the Agrochemicals Association of Kenya of which 0.4% shall be used by the Board to train end-users and other stake holders on safe use of products and the remaining 0.4% shall be remitted by the Board to the Association for the same purpose of training.
|
SCHEDULE
LICENSING OF PREMISES
|
