Zanzibar Food, Drugs and Cosmetics (Iodated Salt) Regulations 2009

1 THE ZANZIBAR FOOD, DRUGS AND COSMETICS ACT, 2006 REGULATIONS Made under sections 27 (2) (a) THE ZANZIBAR FOOD, DRUGS AND COSMETICS (IODATED SALT) REGULATIONS, 2009 ARRANGEMENT OF REGULATIONS Regulation 1. Short title and commencement 2. Interpretation 3. Restriction on issue of permit for producing common salt 4. Cancellation of permit for producing common salt 5. Prohibition of Import of Salt 6. Requirement for edible salt 7. Prohibition on Manufacture, Store or Sale of Salt 8. Conditions for Packing and Labelling of Iodated Salt 9. Conditions for dealers in iodated salt 10. Submission Returns 11. Inspection 12. Penalties 13. Compounding offences SCHEDULE 2 THE ZANZIBAR FOOD, DRUGS AND COSMETICS ACT, 2006 REGULATIONS Made under sections 27 (2) (a) THE ZANZIBAR FOOD, DRUGS AND COSMETICS (IODATED SALT) REGULATIONS, 2009 Citation Interpretation 1. These Regulations may be cited as The Zanzibar Food, Drugs and Cosmetics (Iodated Salt) Regulations 2009 and shall come into operation upon the date where by the Minister may assign. 2. in these regulations, unless the context otherwise requires; “Authorised Officer” means an officer appointed under section 106 of the Act; “Board” means a Zanzibar Food, Drugs and Cosmetics Board established under section 3 of the Zanzibar Food, Drugs and Cosmetics Act No. 2 of 2006; “Dealer” means a person or body corporate carrying on directly or otherwise, the business of buying, selling, supplying or distributing iodated common salt which is obtained directly from the producer. “Display” means offer for of iodated salt for sale; “Inspector” shall be prescribed according to the meaning in the Act; “Iodated Salt” means a salt fortified with iodine in the form of iodated in accordance with regulation 6; “Laboratory” means any laboratory as specified under section 13 of the Act; “Manufacturer” shall be prescribed according to the meaning in the Act; “Minister” means the minister for the time being responsible for health; “Package” means a box, bottle, casket, tin, barrel, container, case, receptacle, sack, jute bag with internal polythene lining or a polythene bag in which iodated salt is placed or packed; 3 “Packer” means a person who packs iodated salt in a packet in quantity suitable for sale whether wholesale or retail; “Principal display panel” in relation to a package, means that prominent part of a package which is intended; or is likely to be displayed, presented or shown to or examined by the customary conditions of display; “Producer” means a person or body corporate engaged in mining or producing salt; “Registrar” meaning the Registrar of the Zanzibar Food, Drugs and Cosmetics Board appointed by the Minister; “Salt” means edible salt that is crystalline solid, white or pale, or light grey colour consisting predominantly of sodium chloride obtained from sea, underground rock, salt deposits or natural brine and free from visible contamination with dust, dirt, clay, grit or any other extraneous adulterant or impurities; Restriction on issue of permit for producing common salt 3. Any person or body cooperate wishing to obtain a permit for producing common salt as defined in these regulations shall state clearly the intended place of the common salt and if the common salt is intended for human consumption he shall present a report on the following: a) type of salt deposit, whether seawater, underground brine, rock salt, or otherwise; b) method of mining and or production of iodated common salt and its byproducts, whether by solar evaporation, direct boiling of brine, vacuum evaporation; and c) Information regarding the quality of salt, the level of iodine in the natural state of salt deposit obtained in the course of prospecting and or mining. Cancellation of permit for producing common salt 4. (a) Issuance of a permit is a subject to a satisfaction of a Board on the ability of the applicant to fulfill the requirements of these regulations and any other regulations made under the Zanzibar Food, Drugs and Cosmetics Act No.2, 2006. (b) the Board may cancel a permit of any person or body cooperate who deliberately fails, refuses or neglect to comply with any provision of these regulations Prohibition of Import of Salt 5. No person shall import into Zanzibar any edible salt in any other form unless such salt is iodated in conformity with regulation 6 of 4 these Regulations. Requirement for edible salt 6. (1) No person shall or cause any other person or on his behalf manufacture for sale or distribute, store or display salt for human or animal consumption unless such salt is iodated in accordance with the Regulations. (2) Not withstanding the provision of any other regulation, salt shall not be iodated unless the same contains moisture not exceeding 4.0 percent of the weight of the undried sample and containing on dry weight basis: i) at least 97.0 per cent by weight of sodium chloride; ii) not more than 1.0 per cent by weight of matter insoluble in water; iii) not more than 2.0 per cent by weight of matter soluble in water other than sodium chloride; and iv) the level of iodine shall be 75 – 100 parts per million at its production; and v) the level of iodine shall be 40 – 75 parts per million at the time of importation; and vi) the level of iodine shall be 25 – 55 parts per million at the point of its sale. Prohibition on Manufacture, Store or Sale of Salt 7. No person shall on his own or cause any other person on his behalf to manufacture for sale or distribution, store or display salt other than iodated salt. Conditions for Packing and Labelling of Iodated Salt 8. No person shall pack, cause or permit to be packed iodated salt for sale, distribution, or delivery unless the package in which the iodated salt is packed bears within the principal display panel, the area of which shall not be less than 40 per cent of the total surface area of the package, legible and unambiguous declaration in Swahili of English language as to: a) the factor that the salt in the package is iodated. b) the complete name and address of the; i. manufacturer, if the manufacturer is also a packer; or ii. packer, if the packer is not the manufacturer, c) the net weight of the iodated salt contained in the package, excluding the weight of the package; d) the month and year in which the iodated salt is manufactured, packed and expire; e) the batch and lot number of the package; and 5 f) storage in a cool, clean and dry place. Conditions for dealers in iodated salt 9. No dealer or other person shall: a) store, display, sell or distribute iodated salt in the package form unless the package complies with, in all respect, the provision of regulation 8, b) sell or distribute iodated salt contained in the package which has been damaged unless the dealer obtains the approval of the authorised officer, or c) Obliterate or alter any declaration made on any package. Submission Returns 10. Any producer of iodated salt shall submit to the Board a monthly production return form, stating the amount of salt produced, iodated or distributed, and other information as the Board may require from time to time. The form shall be submitted in duplicate for every calendar month and shall reach the Board office not later than two weeks after the end of each month. Inspection 11. (1) Any authorised officer may at any time or where there is or reasonable cause of violation of law, inspect any factory or any commercial concern, shop, store, any premises or vessel where edible salt is manufactured, packed or stored as the case may be, and take any necessary action including those mentioned in sub regulation (2) herein; and (2) Subject to sub regulation (1) an inspector may take sample for laboratory analysis or other examination of iodated salt for the purpose of ensuring compliance. (3) Notwithstanding the provisions of these Regulations, an inspector may examine or inspect permit, take legal action or any other action he deems fit against any holder of a permit for dealing with iodated salt who do not comply with the requirements made under these Regulations. Penalties 12. If any person contravenes the provisions of these Regulations, shall commit an offence and shall be punishable with imprisonment for a term not exceeding three years or a fine not less than five hundred thousand shillings or to both such fine and imprisonment Compounding offences 13. (1) The Registrar or the Inspector may, subject to and in accordance with the provisions of the Act, if circumstances show that a person, corporate or unincorporated body has committed any offence 6 against these Regulations in respect to which he has showed willingness to pay a fine or any other thing in respect of which the offence has been committed. (2) The Registrar or an Inspector authorised to act on his behalf before accepting a fine or any other thing from the person referred under sub regulation (1) shall require such a person to fill in a Compounding Form as provided in the Schedule (3) Subject to the provisions of these regulations authorizing any measures that may be taken pursuant to an order of the court, no further criminal or as the case may be, civil proceedings shall be taken against a person in respect of whom a power to compound offence has been exercised. ………………………… Sultan Muhammed Mugheiry, Minister of Health and Social Welfare Revolutionary Government of Zanzibar 7 SCHEDULE Regulation 13 ZFDB FORM No…….. ZANZIBAR FOOD AND DRUGS BOARD COMPOUNDING OF OFFENCES FORM (To be filled in capital letters) 1. Particulars of the person/offender 2. Type of the offence and the penalty For official use Name of the company/person ……………………………………………………………… Postal address ………………………………………………………………………………. Street/Rd ………………………………… Plot/House No. …………………………… Contact person …………………………… E-mail: …………………………………….. Telephone No. …………………………… Fax Number: ……………………………….. Offence……………………………………………………………………………………… Penalty……...………………………………………………………………………………. ……………………………………………………………………………………………… The following product(s)/equipment used to commit the offence were seized: …………,, 8 3. Declaration by the offender 4. Payment (For official use only) 1. ……………………………………………………………………………………………. 2. …………………………………………………………………………………………… 3. ……………………………………………………………………………………………. 4. ……………………………………………………………………………………………. 5. ……………………………………………………………………………………………. 6. ……………………………………………………………………………………………. 7. ……………………………………………………………………………………………. 8. ……………………………………………………………………………………………. 9. ……………………………………………………………………………………………. 10. ……………………………………………………………………………………………. I/We ………………………………….. do hereby admit to have committed the offence specified under the paragraph (2) of this schedule, hence without undue influence, commit ourselves that we are voluntarily willing and accept to pay fine of TZS ……………………. and that, unless by order of the court, no firther criminal or as the case may be, civil proceedings shall be taken against ourselves in respect of this offence to which power to compound offence has been exercised. Full Name ……………………………………………………………………………………….. Signature ………………………………………………………………………………………… Dated at …………………………………..this …………………….day of ……………20…… Amount of fine to be paid……………………………………………………………………… Name and signature of Authorized officer …………………………………………………...... Name of cashier ………………………………….. Signature……………………………….. Receipt Number ……………………………………………………………………………….. Date and stamp ………………………………………………………………………………… NB: Cashier should attach copy of recipet