Food fortification and salt iodisation regulations 2006

REPUBLIC OF THE GAMBIA FOOD ACT, 2005 (2005 NO. 9) FOOD FORTIFICATION AND SALT IODISATION REGULATIONS 2006 REPUBLIC OF THE GAMBIA \ k J FOOD ACT, 2005 ' (2005 NO. 9) ! FOOD FORTIFICATION AND SALT I0DISATION REGULATIONS Printead kv P Cambier Progeengs comet Pabhihiang Coeporatton (G110 FOOD FORTIFICATION AND SALT IODISATION REGULATIONS, 2006 ARRANGEMENT OF REGULATIONS Regulation PART I - PRELIMINARY 1. Citation 2. Interpretation PART 11- FOOD FORTIFICATION 3. Application of this Part 4. Food fortification requirements 5. Food importation etc. requirements 6. Importation of food not meeting requirements 7. Exportation of food not meeting requirements 8. Possession or control of food not meeting requirements 9. Presumption of warranty by importer, etc. that food meets requirements 10. Requirement as to licence 11. Application for and issuance of licence 12. Validity of licence 13. Denial of renewal 14. Restriction, etc. of licence 15. Right to be heard 16. Establishment of internal quality assurance procedures 17. Duty to protect and preserve composition, quality, etc. of food in packaging 18. Duty to protect and preserve composition, quality, etc. of food during storage and transport PART Ill - SALT IOD!SATION 19. Application of this Part 20. lodisation of salt 21. Registration 22. Duty of Agency to monitor salt producers and manufacturers 3. Duties of producers, etc. of food grade salt 4. Requirement as to licence 5. Certificate of training 6. Use of iodised salt in manufacture of food grade salt 7. Use of iodised salt in food outlets, etc. 8. Sale of iodised salt 9. Expiration of iodised salt 0. Duty of Agency to monitor implementation 1. Quality assurance activities 'ART IV - MISCELLANEOUS 2. Offences ISSN 0796 - 0271 Supplement "A" to The Gambia Gazette No. 18 of 18th July, 2006 Legal Notice No. I 5 of 2006 77 REPUBLIC OF THE GAMBIA Citation Interpretation FOOD ACT, 2005 {2005 NO.9) FOOD FORTIFICATION AND SALT IODISATION REGULATIONS, 2006 IN EXERCISE of the powers conferred on the Secretary of State for Health and Social Welfare by section 43 of the Food Act, and on the advice of the National Nutrition Agency, these Regulations are hereby made. PART I - PRELIMINARY 1. These Regulations may be cited as Food Fortification and Salt lodisation Regulations, 2006. 2. (1) In these Regulations, unless the context otherwise requires- Food Fortification and Salt Iodisation Regulations, 2006 "Act" means the Food Act, 2005; "additive" has the meaning given to it in the Act; "advertisement" has the meaning g[ven to it in the Act: "Agency" means the National Nutrition Agency established under section 4 of the Act: "analyst" has the meaning given to it in the Act; "authorised officer", in relation to the performance of a function, means the officer who has been issued with an authorisation to perform that function; "Board" means the Agency Board established for the Agency under section 5 of the Act; "Director" means the Director of Health Services in the Department of State for Health and Social Welfare: "distribution" means the exchange, supply delivery, sale or disposal of food grade salt, whether for remuneration or other consideration. "distributor" means a person who distributes, sells or imports salt for distribution to retailers; "essential nutrient" means any substance, normally ingested that is necessary for growth, development and maintenance of health and which is not synthesized in adequate amounts by the body; Food Fortification and Salt Iodisation Regulations, 2006 79 Schedule "foodn means food required to be fortified under regulation 4 and Part Ill; "food fortification" means the addition of nutrients to processed food at levels above the natural state, "food grade salt" means animal consumption as industrial salt; salt for human and distinguished from "food service establishment" includes hotels, restaurants, catering firms, hospitals and other related outlets which serve or sell food to consumers; "fortificant", in relation to the process of salt iodisation, means a potassium iodate or other suitable fortificant as recommended by the Board; "handle" includes pack, decorate, serve, store and transport; "industrial salt" means salt used in the treatment, processing or manufacture of non~food commercial products; "iodised salt" means salt fortified as set out in the Schedule to these Regulations; "logo" means a symbol authorized by the Secretary of State for us13: on the packaging or label of certain foods to signify approval by the Government; Food Fortification and Salt Iodisation Regulations, 2006 Application of this Part Food fortification requirements - "regulatclry requirement" means the provisions of all applicable laws or regulations relating to food quality and safety and any other aspect of food regulation or control; "Secretary of State" means the Secretary of State for Health and Social Welfare; "sub-standard food" means food, that does not comply with a standard applicable to it or to food of that kind. (2) A word or expression used in these Regulations, which is defined in the Act, has the meaning given to it in the Act. PART II - FOOD FORTIFICATION 3. The provisions of this Part- (a) apply to all food sold, imported, packaged, manufactured, displayed for sale, labelled, stored, distributed or exported from The Gambia; and (b) do not apply to food grown or cultivated by an individual for his or her domestic use. 4. ( 1) The Secretary of State may, on the advice of the Agency, by Order published in the Gazette, establish food fortification requirements for a particular food not specified in Part Ill. (2) Whme these Regulations or an Order of the Secretary of State requires the fortification of a particular food, the Secretary of State may Food Fortification and Salt Iodisation Regulations, 2006 Food importa­ tion, etc. requirements Importation of food not meet­ ing require­ ments authorize a licensee on application to import, manufacture, distribute or sell a quantity of that food at specified locations and under the conditions prescribed in these Regulations. 5. Subject to the provisions of regulation 4 (2), a person who imports, manufactures, packages, advertises, sells, distributes, stores or exports food shall do so in accordance with the provisions of these Regulations. 6. ( 1 ) Where a food that does not meet the requirements of these Regulations is imported into· The Gambia, an authorised person may- (a) confiscate the food; or (b) direct that the food so imported be re­ conditioned, re-labelled, re-packaged, or otherwise treated, to bring it into con­ formity with these Regulations. (2) Whilst a food is being treated pursuanl to a direction under paragraph (1)- (a) it shall be identified and stored sepa­ rately from other foods; (b) (c) it shall be treated within a period specified in these Regulations or in the direction; it may be subject to forfeiture and destruction; (d) the person concerned with the impor­ tation may, in addition, be charged with an offence under these Regulations and punished, accordingly. 81 Food Fortification and Salt Iodisation Regulations, 2006 Exportation of food not meet­ ing require­ ments Possession or control of food not meeting requirements Presumption of warranty by importer, etc. that food meets requirements 7. Where a person intends to export food that does not meet the requirements under these Regulations but meets the requirements of the country it is being imported into, the food- (a) may remain in The Gambia for a period of one month; (b) shall be clearly labelled as intended for export only; (c) shall contain a warning that it is not authorised for sale or consumption in The Gambia; and (d) shall be stored separately from other foods. 8. Where a seller or distributor has food in his or her possession or control which does not meet the requirements of these Regulations, he or she shall- (a) return ii to the source from which it was purchased; (b) recondition it within one month; (c) re-label it purposes; or (d) destroy it. for non-consumption 9. A person who imports, manufactures, dis­ tributes, sells or exports food is deemed to warrant to a purchaser that the food - (a) was handled in conformity with the requirements of these Regulations; and Food Fortification and Salt Iodisation Regulations, 2006 Requirement as to licence Application for, and issuance of licence Validity of licence Denial of renea.val Restriction, etc. of licences (b) meets the specifications on its label and in any advertisement. 10. An importer, manufacturer, distributor, seller or exporter of food shall not operate or advertise its business without a licence issued in accordance with these Regulations. 11. (1) An application for a licence shall be made to the Agency in such manner and form as it may specify and be accompanied by the prescribed fees. (2) The Agency shall issue a applicant who has complied Regulations. licence with to an these 12. A licence is valid for a period of one year and may be renewed at the end of every year. 13. A licensee who- (a) falls to meet the requirements of these Regulations; (b) has had a licence restricted, suspended or revoked within the previous twenty­ four months; or (c) has constantly not complied with the requirements of these regulations, may be denied a renewal. 14. The Agency may restrict, suspend or revoke a licence where the licensee does not comply with the requirements of these Regulations. 83 Food Fortification and Salt Iodisation Regulations, 2006 Right to b-e heard Establishment of internal quality assurance procedures Duty to protect and preseNe composition. quality, etc. of food in packaging 15. (1) An applicant who has been denied a licence or issued a restricted licence may, within fourteen days of the notification of the denial or issue of the restricted licence, request for an administrative hearing by the Secretary of State. (2) The Secretary of State shall. within thirty days of receiving an applicaiion under paragraph (1), take a final decision which he or she shall communicate to the applicant. 16. A person who imports, manufactures, exports, sells, or packages food shall establish internal quality assurance procedures in accordance with these Regulations to ensure compliance with specified standards. 17. A person who packages food shall- ( a) do so in a manner that protects and preserves the composition, quality, purity, hygiene and safety; (b) protect it from harmful or contaminating substances, agents or effects; (c) protect its nutritive properties from excessive heat, moisture and other conditions that may cause diminution; (d) label and advertise the food in a manner that is true and accurate and not likely to mislead the consumer; and (e) do so in accordance with these Regu­ lations. Food Fortification and Salt Iodisation Repulations, 2006 Duly to protect and preserve composition, quality, etc. of food during storage and transport Appllca!ion of this Part lodisation of salt Schedule 18. A person shall store or transport food in a manner that- (a) protects and preserves its composition, quality, purity, hygiene and safety; (b) protects its nutritive properties; and (c) protects it from harmful or contaminating substances, agents or effects. PART 111- SALT IODISATION 19. This Part applies to the salt industry, including salt producers, manufacturers, importers, traders and distributors, and government and non­ government agencies involved in salt iodisation activities. 20. All salt intended for human or animal consumption, unless exempted, shall be iodised in accordance with specifications and standards set out in the Schedule. Registration 21. A producer or manufacturer of salt shall register with the Agency or such other body as the Agency may designate, which shall maintain a register of salt producers and manufacturers. Duty of Agency 22. The Agency shall• to monitor salt producers and manufacturers (a) monitor compliance of salt producers and manufacturers with the provisions of this Part; (b) establish a system to monitor the quality of iodised salt; and 85 Food Fortification and Salt lodisation Reo-ulations, 2006 Duties of producers, etc. of food grade salt Requirement as to licence (c) determine the volume of production and sate of the locally manufactured or imported salt. 23. A producer, manufacturer or distributor of food grade salt shall- (a) iodise the salt produced, manufactured, imported, exported or sold; (b) not expose the salt to rain, excessive humidity, direct sunlight or strong heat at any stage of its storage, transportation or sale; ( c) transport, store and sell iodised salt in the bag in which it was originally packed; (d) dispatch, distribute or sett iodised salt strictly according to the principle of first in, first out; (e) maintain the proper identification and segregation of iodised salt from non­ iodised salt; (g) label the salt in a manner that is true, accurate and not likely to mislead the purchaser and in accordance with these Regulations; and not stack salt on any surface that is less than four inches from the floor level. 24. A manufacturer, an importer or a distributor of iodised salt shall not operate without a licence issued in accordance with Part II. I 1 Food Fortification and Salt Iodisation Regulations, 2006 Certificate of training Use of iodised salt in manufacture of food Use of iodised salt in food outlets, etc. Sale of iodised salt Expiration of iodised salt Duty of Agency to monitor implementation 25. A person engaged in manual salt iodisation shall secure a certificate of training from the Agency before being given a licence to operate. 26. (1) A manufacturer or processor of food, which requires the use of food grade salt, shall use iodised salt in the processing or manufacture of the food. (2) A manufacturer or processor referred to in paragraph (1) shall comply with the provisions of these Regulations not later than six months after, the coming into effect of these Regulations. 27. A person who owns a food outlet, restaurant, store or other establishment where food is prepared or sold shall use or ensure that iodised salt is used in the preparing of the food sold. 28. Iodised salt shall be distributed and sold according to the principle of first in, first out, and sold at retail or final distribution within a period of not more than thirty-six months from the date of manufacture. 29. Iodised salt shall expire thirty-six months after the date of manufacture and shall thereafter be replaced or returned to the last seller or distributor in the manufacturing-distribution chain. 30. (1) The Agency shall monitor the implement­ ation of this Part and shall- (a) (b) support a public information drive; provide training technology and control; on salt iodisation quality assurance 87 Food Fortification and Salt lodisation Regulations, 2006 (¢) determine the volume of production and sale of the locally manufactured or imporied salt. D”tjjescgf . 23. A producer, manufacturer or distributor of food plogucers. = grade salt shall- salt (a) iodise the salt produced, manufactured, imported, exported or sold; {b) not expose the salt to rain, excessive humidity, direct sunlight or strong heat at any stage of its storage, transportation or sale; {(c) transport, store and sell iodised sait in the bag in which it was originally packed; (d) dispaich, distribute or sell iodised salt strictly according to the principle of first in, first ouf; (e) maintain the proper identification and segregation of iodised salt from non- jodised salt; (f)y labe! the salt in a manner that is true, acourate and not likely to mislead the purchaser and in accordance with these Regulations; and (@) not stack salt on any surface that is less than four inches from the floor level. tReiqUifment as 24. A ranufacturer, an importer or a distributor of o licence iodised salt shall not operate without a licence issued in accordance with Part 11. Food Fortification and Salt Iodisation Regulations, 2006 &7 Certificata of training Use of iodised saltin manuiacture of food Use of indised salt in food outiets, etc. Sale of indised sait Expiration of indised salt Buty of Agency 6 monitor implementation 25. A person engaged in manual salt iodisation shall secure a certificate of training from the Agency before being given a licence to operate. 26. (1) A manufacturer or processor of food, which requires the use of food grade salf, shall use iodised salt in the processing or manufacture of the food. (2) A manufacturer or processor referred o in paragraph (1) shali comply with the provisions of these Regulations not fater than six months after. the coming into effect of these Reguiations. 27. A person who owns a food ouflet, restaurant, store or other establishment where food is prepared or sold shall use or ensure that jodised salt is used in the preparing of the food sold. 28. lodised salt shall be distributed and sold according to the principle of first in, first out, and sold at retail or final distribution within a period of not more than thirty-six months from the date of manufacture. 29. lodised salt shall expire thirty-six months after the date of manufacture and shall thereafter be replaced or returned to the {ast seller or distributor in the manufacturing-distribution chain. 30. (1) The Agency shall monitor the implement- ation of this Part and shatl- (a) support a public information drive; (b) provide ftraining on salt iodisation technology and quality assurance control; Food Fortification and Salt Iodisation Regulations, 2006 (c) (d) (e) set and enforce standards for food grade iodised salt and monitor compliance; establish and maintain a register of sa!t producers in each Local Government Area; and facilitate the establishment of a health notification system for cases of hyper­ thyroidism at selected health institutions. (2) The list mentioned in sub-paragraph (f) of paragraph ( 1 ) shall contain- (a) the name and address of company or owner; (b) the location of salt production site; (c) the annual production capacity; (d) the type of salt produced namely- (i) food grade (coarse or fine), (ii) iodised salt, and (iii) non-iodised salt; (e) the distribution channels, namely- (i) direct sale to consumers within the Local Government Area, (ii) traders within the Local Government Area, (iii) traders from other Local Govern­ ment Area, Food Fortification and Salt Iodisation Regulations, 2006 Quality assu­ rance activities (iv) food manufacturers within the divi­ sions, and (v) exporters of salt. 31. A manufacturer of salt shall, in order to ensure the quality of iodised salt prior to distribution, conduct quality assurance activities, including but not limited to the following- (a) collecting sample·s of iodised salt from the production line and testing the iodine content at regular intervals on a daily basis; (b) inspecting equipment at least twice daily to ensure its proper operation; (c) monitoring the mixing process regularly to ensure consistent mixing and homogeneity of iodine content in the batch being processed; (d) collecting samples of each batch of salt that is ready for distribution to ensure conformity with prisscribed iodine level; (e) conducting packaging and labelling inspection regularly to ensure that the labelling conforms to the prescribed requirements; (f) maintaining a daily control chart and weekly summary of activities and taking corrective actions, if any, for a period of at least twelve months from the date of manufacture of the iodised salt; 89 Food Fortification and Salt Iodisation Re 0 ulations, 2006 (g) providing a certificate of iodisation of the specified batch to the distributor or seller; and (h} observing personnel and environmental hygiene throughout the process. PART IV - MISCELLANEOUS Offences 32. A person who contravenes a provision of these Regulations or an Order made under these Regulations commits an offence and is liable on conviction to a fine of not less than twenty thousand dalasis or imprisonment for a term of not exceeding two years, or to both the fine and imprisonment. SCHEDULE (regulations 2 and 20) IODISING SPECIFICATION AND STANDARDS 1. A person who manufactures, produces, packages, labels, stores, transports, sells, distributi9s, imports or exports iodised salt shall conform to the standard requirements as set out in this Schedule. 2. The standards set out in this Schedule also apply to iodised salt used as a condiment or an ingredient in the preparation of food in households, food service and food manufacturing establishments. 3. Food grade salts shall be- (a) produced from brine and refined or unrefined salt obtained from underground rock salt deposits; Food Fortification and Salt Iodisation Regulations, 2006 91 (b} in the form of so!:id crystal or powder; (c) iodised with potassium iodate (KIO3) or potassium iodide (Kl) by means of any of the following methods- (i) dry mixing, if salt is in powdered form, (ii) drip feeding or spray mixing if salt is in crystal form, or (iii) submersion of salt crystals in iodated brine. 4. (1) To ensure the stability of iodine, salt to be iodised shall contain the following requirements- (a) moisture 3% for refined sa!t; {b) NaCl 9.-S¾ for unrefined Salt; (c) insolubles 0.5%; (d) sulphate 0.5 mg/ kg; (e) Calcium 0.2 mg/kg; (f) Magnesium 0.1mglkg. (2) Notwithstanding sub-paragraph (1), raw salt may contain natural secondary products, which are present in varying amounts depending on the origin and method of production of the salt such that- (a) the sulphate content shall not be more than 5glkg or 0.5% expressed as SO,; Food Foitification and Salt Iodisation Regulations, 2006 (b) the magnesium content shall not be more than 3g/kg or 0.3% expressed as Mg; and ( c) the calcium content shall not be more than 3g/kg or 0.3% expressed as Ca. (3) Food grade salt shall- (a) not contain contaminants in an amount and in such a form that shall be harmful to the health of the consumer· ' (b) contain the limits prescribed in para­ graph 4(1) which shall be the maximum and shall not be exceeded. 5. The iodine levels in iodised salt shall be as follows- As iodine: As potassium iodate: Production Site 30-50ppm 50-B0ppm Port of Entry 30-50ppm 50-B0ppm Retail Site 20-40ppm 34-66ppm 6. (1). An additive used, including KI03 and Kl, shall be offood grade quality and shall conform to specifications prescribed by the Codex Alimentarius Commission. (2) Permitted additives for iodised salt are as follows- (a) anti-caking agents, namely- Food Fortification and Salt lodisation Regulations, 2006 93 (i} Coating agents (must not exceed 20g/kg singly or in combination) Carbonnates of Calclum/Magne· sium, Magnesium oxide, Tri·calclum phosphate, Silicon dioxide, (ii) Coating hydrophobic agents (must not exceed 20g/kg singly or in combination) Aluminium, Calcium, Magnesium, Potassium or sodium Salts, Myristic, Palmitic or Stearic acid, (iii) Crystal modifiers (must not exceed 10g/kg singly or in combination) Ferrocyanides of calcium, Potas· sium or sodium Expressed{Fe(CN)}; (b) emulsifiers- Polysorbate 80 (c) processing aid­ Dimethylpofysiloxane 10mglkg; 10mg of residue/kg 7. Iodised salt must not contain a large quantity of potentially injurious substances in the form or amounts that can be harmful to the consumer. If present must not exceed the following maximum quantities• (a} Arsenic (b) Copper (c} Lead 1mg/kg; 2mg/kg; 2mglkg; Food Fortification and Salt Iodisation Regulations, 2006 (d) Cadmium 0.Smg/kg; and (e) Mercury 0.1mglkg. 8. A manufacturer or producer of salt shall- (a) pack the salt in a woven polypropylene bag, a clean unused jute bag or other non­ porous material with a lining of high-density polyethylene to ensure the retention of appropriate iodine level at the time of consumption; (b) label the salt in accordance with these regulations and shall specify the following information on each container of iodised salt whether in bulk or a retail package; (c) for locally produced iodised salt, state- (i) the name of the product, and "IODISED SALT", printed in bold capital letters, (ii) the name and address of manufacturer, (iii) the net weight (in metric units) (iv) the iodine compound used, (v) the chemical additives, for example, anti-caking agents, (vi) the open date marking for example "Best Before" or "Consume Before" date; date manufactured, (vii) the lot identification codes (re­ packers) must use manufacturers lot), and Food Fortification and Salt Iodisation Regulations, 2006 9.'." (viii) the storage instructions "STORE IN A COOL DRY PLACE"; (d) for imported iodised salt, state- (i) the name of importer or local distribu­ tor, (ii) the country of origin, (iii) the name of the product, "IODISED SALT", printed in bold capital letters, (iv) the net weight (in metric units), (v) the iodine compound used, (vi) the chemical additives, for example anti-caking agents, ' (vii} the open date marking for examo!e "Best Before" or "consume befo 0 re" date; date manufactured, (viii) the lot identif;cation codes (re-pac­ kers) must use manufacturers lot), (ix) the storage instructions "STORE IN A COOL DRY PLACE"; (e) where the salt is packed in non-retail containers of at least 25kg, state on the container- (l) the name and address of manufacturer (ii) the iodine compcund used, ' Food Fortification and Salt Iodisation Regulations, 2006 (iii) the chemical additives, for example, anti--caking agents, (vi) the storage instructions "STORE IN A COOL DRY PLACE"; MADE this 20"' day of June 2006 TAMSIR MBOWE SECRETARY OF STATE FOR HEALTH AND SOCIAL WELFARE