Food and Drugs (Control of Quality) (Iodated Salt) Regulations, 1997 (S.I. No. 59 of 1997)

a,· STATUTORY INSTRUMENTS SUPPLEMENT No. 22 24th October, 1991 STATUTORY INSTRUMENTS . SUPPLE."1ENT to Tiu, Uganda Ga,ett, No.68 Vo/um, XC dated 24th Occolur. 1997 . . ' . Printed by UPPC. Entebbe. by. ~er of Govemmcnt. . . THE FOODS AND DRUGS (CONTROL OF QUALITY) (IODATED SALT) REGULATIONS, 1997. Reg11lations I. Cirniion. 2. Interprcta1ion. 3. Application. 1) Establishment of Council. 5. Functions of Council. ~ Composi1ion of Council . , 7. Meetings of Council. 8. Iodation of sail. 9. Packaging of iodated salt. 10. Labelling of iodated salt. 11 . Period of sale of salt . 12. Storage and transportalion of salt. @ Establishment of laboratories. • 14. Functions of laboraiories. 15. On the spot checks. 16. Samples for testing salt. 205 17. Inspection of salt factories, etc. I 8. Salt below standard not to enter market. 19. Other salt standards. 20. Sensitization of the public. 21. Offence and penalties. 22. Quality ll$Surance activities. SCHEDIB..E '\ :': ,.,. ' ; . ' . .. . . . " S T A T U T O R Y I N S T R U M E N TS. 1997 No. 59. ')l . ,,r., ., ')" ,, . ' .. , , •• . • • .... ., I ''. T,~e Foods and Drug~ (Control of Quality) (Iodated Salt) :, 2 ·;;,.:; -. ,,:, : ,1.,, : ~egulations, 1997. ·, . !1i;·,·r:.1il ' (Under section 42 of rhe Foods and Drugs Act. / IN EXERCISE of the powers conferred upon the Minister by subsection I of section 42 of the Foods and Drugs Act, these Regulations rue 111atle this 123rd day of September, 1997. I. These Regu lations may be cited as the Foods And Drugs (Control of Quality) (Iodated Salt) Regu lations, 1997. 2. In these Regulations, unless the context otherwise requires .• : .:; :.:; 1· : . ;-. ."authorised Officer" means an officer given the mandate or appointed by the Minister to carry out duties under the provisions of these regulations; ) "Council" me~ns the inter-sectoral National Council for '. the Control of Iod ine Deficiency Disorders (NCCIDD) established in Regulation 4; "imported" means with respect to iodated salt, salt brought into Uganda .from another country for distribution in Uganda; "iodated salt" means salt in tended for human or livestock consumption to which potassium iodate has been added as a means of preventing iodine deficiency disorders; "Minister" means the Minister responsible for health; "Ministry" means the Ministry responsible for health; "package" means anything in which iodated salt is partially or wholly covered, wrapped, attached, enclosed, contained or packed; 207 C.p, 271. Cit.a.lion. ln1crprc 1:1.1ion. Application, Esiablish-,\ mcnt or Counc-il. Fut1clion.s of ·counc-iJ. "produced" means with respect to jodated salt the making, processing or manufact. 1 of salt; "salt laboratory" means a room or building equipped to test characteristics of salt including iodine content in accordance with the Uganda Food Grade Salt standard as prescribed by the National Bureau of Standards Act, 1983; "marketed" means with respect to iodated salt the state of salt trade as shown by prices or the rate at which iodated salt is bought and sold in Uganda; , . . . . ''.sample" means a quantity° of a salt product provided for analysis or examination. 3. These Regulations shall apply to all salt for human and livestock consumption, imported, produced or marketed in Uganda. 4. There is established an inter-sectoral National Counf'i\ for the Control of Iodine Deficiency Disorders (NCCIDD) in tli&-' Ministry responsible for health. 5. The functions of the Council shall be ( a) to advise on the policy relating to the control of iodine deficiency disorders; (b) to devise strategies for the control of iodine ' dificiency disorders; ( c) to oversee the implementation of, the control of iodine deficiency disorders; . . ,, .• ,l (d) to coordinate ~d monitor iodine deficiency disorder control programmes; · · ( e) to advise the relevant authorities on the appropriate approaches for developing effective information() 208 ar education and communication strategies for the , control of iodine deficiency programmes; , ,(/) to advise the Minister and other relevant authoriti' S · · ' {>n designing national strategies for .,. ' . (i) the promotion of research on iodine deficiency disorders; {ii) ensuring continuing medical educaion for health workers on iodine deficiency I disorders; (iii) the incorporation of iodine deficiency · disorders in the education and training of students in health professions; : L. : ') (iv) the incorporation of iodine deficiency disorders, education and training in the curricula of primary, post primary and tertiary institutions; and I : • (g) the carrying out of any other duty that the Minister may direct. . ,.1. ,: . . 6. The Council shall consist of I ... . . . ( a) the Commissioner for Health Services (Nutrition) or representative; (b) the Assistant Commissioner for Health Services (Environmental Health) or representative; . (c) one representative from the Ministry responsible for (i) Trade and Industry; (ii) Education; (iii) Information; (iv) Justice; ( v) Finance; (vi) Gender and Community Development; 209 · Compo· sicion of Council, Pf ri?tl' of Coul>cil ') . . (vii) Lx:al Government; "\'' (viii)Agriculture, Animal lna~Jtry and Fisheries; (d) one representative from each o: the following Organisations (i) the Uganria National B·Jreau of Stanjards; (ii) the salt importers; (iii) th~ salt wholesalers and retailers; (iv) the salt miners; (v) Ncn-Govemmental Organisations; (vi) the Uganda Manufactarers Association; ( e) two representatives of the National Universities in Uganda; (f) one representative of United Nations (UNICEF) as ex officio member; f (g) or.e representative of the World Health Organisation {WHO) as ex officio member, (2) The merr.bers of the Council under paragraphs (c), (d) and ( e) shall be appointed by the Miniser on the recommendation of the relevant Miniscry or Organisation on terms and conditions that the Minister may determine. (3) Tne Minister shall appoint one of the members o. the Council to be Chairperson. 7. (I) The Council shall meet for the discharge of its business at least four times in a year at s·Jch. times and places as the Chairperson sha:J, in consultation with Council members, determine. . ~ ' · . (2) One third of the members of the Council shall form . a quorum at any meeting of the Council. ' 210 (3) The Chairperson shall preside at all meetings of the~ Council and in his or her absence, a member ,elected by the members present from among their number shall preside. ·~·:.·:::.; .. (4). A question proposed at any meeting of the Council shall be detennined by a sim:ple majority of votes . , ··· .. ,{' . . . of members present and voting. (5) Where there is an equality of votes, the person presiding at the meeting sho.11 hnve a second or , ,casting vote. {6) The Council may invite any person who is not a member to attend any of its meetings as an adviser and that person may speak on any matter in relation to which his or her advice is sought but shall not have the right to vote on any matter before !he meeting. (7) Subject to the foregoing provisions the Council shall regulate its own pro<>edure. 8. J\'. I) A person shall not import, produce or market i.n Ug"lffiifa for human or livestock consumption, any salt unless it is iodate d with patassium iodate. , (2) The salt referred to under sub regulation (I) shall be iodated to confonn, ~t each specific stage, to the !~v el~ ~oecified in ·the Schedule to these Regulations and to ensure that the arinimum effective level of potassium iodate is retained in the salt at the time of consumption . . ..... ,, •• +. • • ' • . 'i" ,;:. ,; ; (3) The iodine compound allowed in the salt for human or livestock consumption is potassium iodate . ... ... , :., , 9. (1) Iodated salt shall be packaged or packed in properly labelled, moisture proof and air-tight containers or jute bags lined with ( a) high Density PG!yethelene (HDPE); 211 lod.-ition ~f Salt. Pad<agicg of iodated salt. Lahclling ofiodalcd sa!L Period of ule of salt. Stooge and lranSJ)ort• : tioo of ult. (b) laminated or non-laminated polypr~ylene (PP); or (c) low Density Polyethlene (LDPE). '·· · (2) In order to avoid the use of hooks for lifting iodated salt bags, bulk packing units shall not exceed fifty kilogrammes. (3) Iodated salt for re-tail sale shall be packed in moisture proof Low Density Polyethylene packages or packets of one kilogramme or five hundred grammes. (4) Types of qags which are normally used for packaging commodities such as fertilizers or chemicals shall not be used for packaging of iodated sail 10 (I) Iodated packages or packets of salt shall be clearly labelled <:>!1 the outside to show the following ( a) the name and address of the manufacturer; (b) the statement that the salt is iodated; ( c) the date and country of manufacture; ( d) the lot or batch number; ( e) the weight of the salt; (j) the date by which the salt must be sold on retail; ( g) the level of potassium iodate in ppm or mg/kg; and (h) the caution label indicating that the salt must be stored in a cool and dry place. 11. A retailer shall sell the iodated salt within nine months from the date of manufacture of the salt stamped O!) the package. . . . . . . , .... . 12. A person dealing in or with salt shall ensure that iodated salt is- ·:, . .~ ( a) stored in a cool, well ventilated and dry place which does not, at any stage,expose it to direct light, excessive humidity or inclement weather; 212 (b) r;,t exposed to any fonn of contamination by dust or any chemicals or mixed with non-iodated salt; (c) stored in a covered room or go-down with adequate aeration and stacked on pallets raised to at least ten point two centimetres (10.2 cm or 2 inches) above the floor; ( d) not in contact with any wall of the storage room or go-down; ( e) not handled by hooks or pointed sharp instruments; lfJ properly .s.tocked and a stock register with batch numbers and date of receipt maintained; (g) transported, stored or kept for sale in the package in · which it was originally packed. 13. There shall be established at specifically designated points quality control laboratories for the examination and ~ -~ nalysjs of samples of all imported and locally produced salt. .. .. 14. A quality control laboratory shall check on the quality of any salt imported or produced in Uganda to ensure that the iodine content in the salt is of the level specified under these Regulations and all the salt characteristics conform with the relevant standards established by law. ; ' ,. 15. In addition to the checks at the designated points under regulation 13, random on the spot checks of salt dhall be ·carried out at the following places (a) at the point of entry or border post; 1o fl<}::1,:,::· :~~~~-- . · ,, . . ..... , ·t . ;-:Jri:i::: .. (!, (bJ ~t. th~ factory or ~ar~):louse of the salt producing or · importing company; ,· ; . ·, . .. 1 . . .. ( c) at the wholesale point; or 7,i'!,' . • . . . . .. ,; . . . ,. C.S:tablish· ment of Jal)ora tories. Fun-ctions · of labora tories. · .• ·, On lhe · spo< checks. " ,, ·'· ~.. .. ... :~ • ,l;' · ••. ·.JliQ ) J,:< : (d) at any point of distribution or sale of salt. -- . 213 S:1mples ror testing salL Inspection ohal1 (actocics, tlC, Sahbelow --to enter marl<el. Other sa!t AaNo.l orl933. ScMitiza 000 of the public. . 16. An authorised officer may, at any ti me, talce samples of salt at the production site.entry point int o the country or point of distribution or sale for testing the iodin e content of the salt by rapid salt ·test kit or for detailed la boratory testing under regulation 13 · · 1 '···· - "· i • - ,I ' .; • • • : ' •• 17. Subject to these Regulations and any o ther Jaw in force, an authorised officer may, during norm al office hours or other reasonable time · · . ' ( a) inspect any factorr, commercial co ncern, shop or store; and (b) in connection with the inspection ·' · (i) enter any premises or vessel whe re salt is manufactured, packed, stored or sold; an d (ii) examine and make copies of any book or . records; and. ··:· · , .. ·.·, ·- · ' ' . . .,, · r ,,. •· 1,.. , ' ' , ,'\1 (iii) interview employees or agents to d etennine (::'.:-, whether these Regulations are being com plied Vo• with. , .. 18. For the avoidance of doubt any salt which does not meet the required iodine content or other st andard required by law shall not be allowed to enter into Ugand a or the Uganda market. 19. Iodated salt offered for sale or distribut ion in Uganda shall confonn to other minimum standa rds specified under the Uganda National Bureau of Standards A ct, No. l of 1983, and by any other law in force. ~\ 20. The Ministry shall be responsible for the sensitization of the public, including salt traders, about t he necessity and benefits of consuming iodated salt. · · 21. (l)A person contravening a provision of the se Regulations commits an offence and is liable on co nviction to the relevant e 214 penalty under the Act or the National tlureau 01 ::;ianaaras Act. ,,,.. (2) In additiqn to the penalty prescribed under Sub regulation 1, the following shall be imposed . ·: . (a) where the consignment of salt does not conform to the requirements of these Regulations, the salt shall be down-graded as salt unfit for human or . • ,i;1.' • · . ·· · livestock consumption and shall not be allowed in the Uganda Market; ( b) in case of imported salt, the consignment shall be refused entry into Uganda and shipped back to the •• :,, p< • supplier at the importer's expense; . ( c) in case of locally manufactured salt the consignment shall be kept in bond until iodated to the required . .. , ;,-.-:~ . ~ levels by the supplier; (d) where non-iodated salt is found stocked or being sold by a retail trader, the salt shall be impounded for disposal and destruction on the orders of an authorised officer; and ( e) in case of damage of the original package, a suitable alternative shall be used on condition that all the lebelling on the original package is clearly and correctly indicated on the alternative package. 22 {I) A person importing, producing or r,elling iodated salt shall carry out quality assurance activities which shall, as may be applicable, include but not limited to ' ( a) routine instrument and equipment calibration and maintenance checks; (b) routine quality checks of raw matepals; ( c) routine chemical tests on samples of salt; 215 r,t,.':t. l 'tU. of 1983. Quality assurance activities. . -- ( d) routine inspection of packages and labels; and · ...• ( e) routine inspection of storage areas. -d:.Z. ;J • .'l. .. + - • • d) A pers~n ~~i~~ out quai'ity ass~r~n~e: a~~;~J::~ rshall keep records of the activities for two years and the records ;shall;'as .may,be applicable, specify-· · ,· -: ;,'; ~o ,.srr'.v:?dfii{;;bit~ii'~r lot ~~mbe; ~nd the ~i~tity from which ' I • • ) ! j • ., .,.. , • ;.r ·. samples were taken for analysis; (b) the sample size that was analysed; (c) the analysis results and the person who perfomed the inspection; ( d) the dates and times of inspections, examination; and ( e) any other activity that may have been carried out, including the nature of the activity and its findings. 04. •:"{! ,., ,. ! , .-· I ( SCHEDULE [Regulation 8 Recommended levels of iodine by ICCIDD/UNICEF/WHO. Parts of iodine per million parts of salt i.e micrograms per gram, milligrams per kilogram or grams per ton. Climate and Requirement Requirement Requirement at ,,iJai1y·sa1"\ at for imponed retail sale .. salt ai point of (Shop/market) co;;, Production (g/perso entry "···· Bulk Retail Bulk Retail Bulk Retail (sack) pack (sack) pack (sack) pack (2kg.) (2kg.) (2kg.) LJiSI 100 80 90 70 80 60 5g. 50 40 4~ 35 40 30 a I0g. Wann dry 90 70 80 60 70 50 or C-OQI moist 45 35 40 30 35 25 5g. l I0g. / / . Cool dry 80 60 70 50 60 45 / ~~ 40 30 35 25 30 22.5 I0g. ' 217 . Dr. C. W. B. C. K.iyonga Minister of Health.