Environmental Management and Co-Ordination (Controlled Substances) Regulations, 2007 (Cap. 387)

[Rev. 2012] E12 - 237 [Issue 1] ENVIRONMENTAL MANAGEMENT AND CO-ORDINATION (CONTROLLED SUBSTANCES) REGULATIONS, 2007 ARRANGEMENT OF REGULATIONS PART I – PRELIMINARY Regulation 1. Citation. 2. Interpretation. PART II – CLASSIFICATION AND CONTROL MEASURES 3. Classification of controlled substances. 4. Packaging of controlled substances. 5. Labelling of controlled substances. 6. Storage, distribution, transportation or handling a controlled substance. 7. Disposal of controlled substance. 8. Advertisement of controlled substances. PART III – LICENSING AND PERMIT PROVISIONS 9. Manufacturing of controlled substances. 10. Application for export. 11. Importation of controlled substances. 12. Application for controlled substances in transit. 13. Application for permit to import or export different quantities. 14. Acknowledgement of application. 15. Communication of decision and issue of licence. 16. Validity and renewal of licence. 17. Condition of licence. 18. Licence not transferable. 19. Revocation or suspension of licence. 20. Variation of licence. 21. Maintenance of a register. 22. Exemptions. 23. Illegal procurement. PART IV – MONITORING PROVISIONS 24. Role of the Authority. 25. Obligation of licensee. 26. Submission of report by licensee. PART V – MISCELLANEOUS PROVISIONS 27. Publication of controlled substances and of persons holding permits. 28. General penalty for offences. 29. Public access to records. 30. Transitional provision. [Rev. 2012] [Issue 1] E12 - 238 SCHEDULES FIRST SCHEDULE – CLASSIFICATION OF SUBSTANCES SECOND SCHEDULE – FORMS THIRD SCHEDULE – FORMS FOURTH SCHEDULE – DECLARATION BY THE RECIPIENT/BUYER OF CONTROLLED SUBSTANCES FIFTH SCHEDULE – REPORT ON THE IMPORTATION/EXPORTATION OF CONTROLLED SUBSTANCES SIXTH SCHEDULE – FEES [Rev. 2012] E12 - 239 [Issue 1] ENVIRONMENTAL MANAGEMENT AND CO-ORDINATION (CONTROLLED SUBSTANCES) REGULATIONS, 2007 [L.N. 73/2007.] PART I – PRELIMINARY PROVISIONS 1. Citation These Regulations may be cited as the Environmental Management and Co-ordination (Controlled Substances) Regulations, 2007. 2. Interpretation In these Regulations, unless the context otherwise requires— “competent authority” means a competent authority on matters relating to controlled substances designated by an importing country; “consumption” means production including imports excluding exports of controlled substances; “controlled substances” means the controlled substances as set out in the First Schedule to these Regulations; “material data safety sheet” includes written instructions given by a manufacturer on how to store, transport or handle controlled substances; “Ozone Secretariat” means the Secretariat for the 1985 Vienna Convention on the Protection of the Ozone Layer and the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer; “Prior Informed Consent” means such consent as may be given by the competent Authority before the importation or exportation of a controlled substance; “production” means amount of controlled substances produced minus the amount destroyed by approved technologies and minus the amount entirely used as feedstock in the manufacture of other chemicals and does not include recycled and reused amounts; “Secretariat to the Multilateral Fund” means the Secretariat for the Multilateral Fund for the Implementation of the Montreal Protocol as established in 1990. PART II – CLASSIFICATION AND CONTROL MEASURES 3. Classification of controlled substances (1) The Authority, shall, in consultation with the relevant lead agency, prepare and submit to the Minister for approval, a list of controlled substances. (2) The list to be prepared under this Regulation shall be divided into three groups as follows— (a) group 1 of the list shall consist of partially halogenated flourochemicals with ozone depleting substances of less than 0.12 and defined as transitional substances; (b) group 2 of the list shall consist of hydrobromoflourocarbons with ozone depleting substances estimated to vary from 0.1 to 1.00; and (c) group 3 of the list shall consist of bromochloromethane with ozone depleting substances. [Rev. 2012] [Issue 1] E12 - 240 (3) The Minister may, on the advice of the Authority, in consultation with the relevant lead agency, ban or restrict the production or consumption of specified controlled substances by order in the Gazette. 4. Packaging of controlled substances No person shall keep, sell or consign for transport a controlled substance unless— (a) the controlled substance is in a container impervious to the controlled substance; and (b) the container is sufficiently strong to prevent leakage arising from the ordinary risks of handling and transport. 5. Labelling of controlled substances (1) No controlled substance shall be supplied without a label on the container. (2) Every label on a controlled substance container shall show— (a) the name of the controlled substance or product; (b) the name and address of the manufacturer of the controlled substance or product; (c) the name of the country of origin of the controlled substance or product; (d) the words “Controlled Substance – Not ozone friendly”; (e) a symbol indicating that the substance or product is harmful to the ozone layer; (f) the name of the seller and address of the premises on which it is sold if supplied on sale, other than wholesale; and (g) the name and address of the supplier if supplied otherwise than on sale. 6. Storage, distribution, transportation or handling a controlled substance (1) No person shall store, distribute, transport or otherwise handle a controlled substance unless the controlled substance is accompanied by the material safety data sheet. (2) Any person producing or importing a controlled substance shall at the time of production, packaging or importation, ensure that the material safety data sheet accompanies the produced, packaged or imported controlled substance. 7. Disposal of controlled substance (1) Any person wishing to dispose of a controlled substance shall inform the Authority which shall ensure that the controlled substance is disposed of in an environmentally sound manner. (2) The Authority shall liaise with the Ozone Secretariat in matters relating to the disposal of a controlled substance. 8. Advertisement of controlled substances Any person who advertises any controlled substances shall ensure that the advertisement carries the words— “Warning: contains chemicals, materials or substances that deplete or have potential to deplete the stratospheric ozone layer”. [Rev. 2012] E12 - 241 [Issue 1] PART III – LICENSING AND PERMIT PROVISIONS 9. Manufacturing of controlled substances (1) No person shall manufacture for sale a controlled substance unless the person has a valid licence issued by the Authority. (2) An application for a licence to produce or manufacture a controlled substance shall be made to the Authority in the prescribed Form 1 set out in the Second Schedule to these Regulations and shall be accompanied by the prescribed fee. (3) Upon the application for a licence under this Regulation, the Authority may grant the licence unconditionally, impose conditions on the licence or refuse to grant the licence. (4) The licence under this Regulation shall be in the prescribed Form 6 set out in the Second Schedule. 10. Application for export (1) No person shall export a controlled substance unless such person has a valid licence issued by the Authority. (2) An application to export a controlled substance shall be made to the Authority in the prescribed Form 4 set out in the Second Schedule to these Regulations and shall be accompanied by— (a) a Prior Informed Consent issued by the competent Authority of the importing country; and (b) the prescribed fee. 11. Importation of controlled substances (1) No person shall import into Kenya a controlled substance unless such person has a valid licence issued by the Authority. (2) The application shall be in the prescribed form and the applicant shall indicate the purpose for which the controlled substance is required. (3) An application to import a controlled substance shall be made to the Authority in the prescribed Form 2 set out in the Second Schedule to these Regulations and shall be accompanied by the prescribed fee. (4) Upon the application for a licence under this Regulation, the Authority may grant the licence unconditionally, impose conditions on the licence or refuse to grant the licence. (5) A licence under this Regulation shall be in the prescribed Form. (6) A person issued with an import licence shall keep a full and accurate record of such importation. 12. Application for controlled substances in transit (1) Any person transporting through Kenya any controlled substance, that is not destined for use in Kenya shall— (a) apply for approval to transport such controlled substance through Kenya; and (b) ensure that the controlled substance is properly packaged and transported in accordance with these Regulations and international standards. [Rev. 2012] [Issue 1] E12 - 242 (2) An application for approval to transport through Kenya a controlled substance shall be made to the Authority in the prescribed Form 3 as set out in the Second Schedule to these Regulations and shall be accompanied by— (a) a copy of the Prior Informed Consent issued by the competent Authority of the importing country; and (b) the prescribed deposit bond which shall be refundable. 13. Application for permit to import or export different quantities (1) Where a person licensed to import or export any controlled substance wishes to import or export the controlled substance in different quantities and at different times, the person shall make an application for a permit for every importation or exportation that is to be made. (2) An application for a permit to import or export a controlled substance in different quantities shall be in Form 5 in the Second Schedule to these Regulations and shall be accompanied by the prescribed fee. (3) Any person issued with a permit to import or export a controlled substance shall submit a copy of the permit to the custom officials at the port of entry or exit. (4) The customs official at the port of entry or exit shall verify that the controlled substance permitted to be imported or exported is in accordance with the conditions set out in the licence and permit. 14. Acknowledgement of application (1) Upon the receipt of any application under these Regulations, the Authority shall screen the application for completeness and shall acknowledge receipt of the application within fourteen days. (2) Where the application is not complete, the Authority shall inform the applicant and shall request the applicant to furnish the Authority with additional information. (3) Where the application is for the importation of a controlled substance, the Authority shall prepare the Prior Informed Consent and submit the same to the competent authority of the exporting country. (4) The Authority shall liaise with the relevant lead agencies in determining the application and where the Authority is satisfied that the applicant meets the requirements set out, the Authority shall approve the application. (5) Where the application does not meet the requirements set out, the Authority shall reject the application. (6) A permit to import or export a controlled substance shall be in the prescribed Form 7 set out in the Second Schedule. 15. Communication of decision and issue of licence The Authority shall communicate its decision to the applicant, in writing, within forty-five days (45) of receipt of the application and shall state the reasons for such decision where the application has been rejected. 16. Validity and renewal of licence A licence issued under these Regulations, shall be valid for a period of one year from the date of issue and may be renewed on application. [Rev. 2012] E12 - 243 [Issue 1] 17. Condition of licence The Authority may impose any conditions upon the licence it deems necessary for the compliance with these Regulations. 18. Licence not transferable A licence issued under these Regulations shall relate only to the specific activity for which it was issued and shall not be transferable. 19. Revocation or suspension of licence The Authority may suspend or revoke a licence where the licensee has contravened any of the conditions set out in the licence or any provisions of these Regulations. 20. Variation of licence The Authority may vary a licence or the conditions of the licence either upon the application of the licensee or on its own motion where new information is available to the Authority or to the licensee and the Authority is of the opinion that the information may affect the conditions imposed on the licence. 21. Maintenance of a register (1) The Authority shall establish and maintain a register in the manner prescribed in the Third Schedule to these Regulations. (2) The register shall contain— (a) information on every application received; (b) information on every decision document; (c) information on every licence issued; (d) a record of controlled substances imported, exported, disposed of or in use in the country; (e) a record of quantities of controlled substances imported, exported, disposed of or in use in the country; (f) a record of returns made by licensees; and (g) any other information that the Authority may deem necessary to preserve. 22. Exemptions The Minister may on the advice of the Authority, in consultation with the relevant lead agencies order in the Gazette that a controlled substance for essential use be exempt from the provisions of these Regulations. 23. Illegal procurement (1) Where an imported controlled substance does not meet the specifications of the licensed controlled substance, the Authority shall require the licensee to— (a) return the controlled substance to the country of origin at the cost of the licensee; or (b) pay for the cost of disposal of the controlled substance by the Authority. (2) The Authority shall revoke the licence of any person in contravention of a licence under subsection (1). [Rev. 2012] [Issue 1] E12 - 244 PART IV – MONITORING PROVISIONS 24. Role of the Authority (1) The Authority shall in consultation with the relevant lead agencies, monitor the activities of the licensees to— (a) determine effects of the controlled substances on human health and environment; and (b) to ensure that the licensees comply with the provisions of these Regulations. (2) In carrying out its monitoring role the Authority shall be responsible for— (a) disposal of controlled substances; (b) periodic reporting to the Ozone Secretariat and the Multilateral Fund Secretariat on the produced, imported, exported or consumed controlled substances; (c) receiving returns from licensees; (d) processing and forwarding Prior Informed Consent to the Competent Authority of the countries of importation; (e) receiving Prior Informed Consent from the Competent Authority of the country of exportation or liaising with the competent Authority of the country of exportation to verify the Prior Informed Consent; and (f) any other matters that the Authority may deem necessary for the effective implementation of these Regulations. 25. Obligation of licensee (1) Any licensee who imports or produces any controlled substances shall ensure that all persons who receive or buy such substances sign a declaration prescribed in the Fourth Schedule to these Regulations. (2) Any licensee who supplies, sells or distributes any controlled substances shall keep a record of the declaration forms and submit the record to the licensing Authority after every six months. 26. Submission of reports by licensee (1) Every person licensed under these Regulations shall make and submit reports containing information relating to the licence, activities undertaken under the licence and conditions imposed under the licence to the Authority after every six months or whenever the Authority may demand. (2) The report shall be in the prescribed form set out in the Fifth Schedule to these Regulations. PART V – MISCELLANEOUS PROVISIONS 27. Publication of controlled substances and of persons holding permits (1) The Authority shall on or before 31st December of every year, publish a list of controlled substances in the Kenya Gazette. This list shall consist of— (a) controlled substances that were imported in the year, together with their quantities; (b) controlled substances that were exported in the year and their quantities; (c) quantities of all controlled substances that were imported or exported in the year; [Rev. 2012] E12 - 245 [Issue 1] (d) all persons holding licences to import and export controlled substances and their annual permitted allocations of the controlled substances. 28. General penalty for offences (1) Any person who contravenes any provision of these Regulations commits an offence and is liable on conviction to a fine not exceeding three hundred and fifty thousand shillings or to imprisonment for a term not exceeding eighteen months or to both such fine and imprisonment. (2) In addition to any sentence that the Court may impose on a person convicted under subsection (1), the Court may direct that the person pays the full cost of disposal of the controlled substance by the Authority. 29. Public access to records Any person may on application to the Authority and upon payment of the prescribed fee have access to any records submitted to the Authority under these Regulations. 30. Transitional provision Any person who is producing, importing, exporting or transporting through Kenya a controlled substance shall within two months of the commencement of these Regulations, comply with the provisions of these Regulations. FIRST SCHEDULE [Regulation 4.] CLASSIFICATION OF SUBSTANCES [Rev. 2012] [Issue 1] E12 - 246 ANNEX C: [Rev. 2012] E12 - 247 [Issue 1] [Rev. 2012] [Issue 1] E12 - 248 [Rev. 2012] E12 - 249 [Issue 1] ANNEX D* ANNEX E SECOND SCHEDULE [Rev. 2012] [Issue 1] E12 - 250 [Rev. 2012] E12 - 251 [Issue 1] [Rev. 2012] [Issue 1] E12 - 252 [Rev. 2012] E12 - 253 [Issue 1] [Rev. 2012] [Issue 1] E12 - 254 [Rev. 2012] E12 - 255 [Issue 1] [Rev. 2012] [Issue 1] E12 - 256 [Rev. 2012] E12 - 257 [Issue 1] [Rev. 2012] [Issue 1] E12 - 258 THIRD SCHEDULE [Rev. 2012] E12 - 259 [Issue 1] [Rev. 2012] [Issue 1] E12 - 260 [Rev. 2012] E12 - 261 [Issue 1] [Rev. 2012] [Issue 1] E12 - 262 [Rev. 2012] E12 - 263 [Issue 1] FOURTH SCHEDULE [Regulation 25(1).] ENVIRONMENTAL MANAGEMENT AND CO-ORDINATION ACT [Cap. 387.] Declaration No. DECLARATION BY THE RECIPIENT/BUYER OF CONTROLLED SUBSTANCE(S) [Rev. 2012] [Issue 1] E12 - 264 FIFTH SCHEDULE [Regulation 26(2).] ENVIRONMENTAL MANAGEMENT AND CO-ORDINATION ACT [Cap. 387.] [Rev. 2012] E12 - 265 [Issue 1] SIXTH SCHEDULE [Regulations 9, 10, 11, 12, 13, 30.] ENVIRONMENTAL MANAGEMENT AND CO-ORDINATION ACT [Cap. 387.] FEES