Food Fortification Regulations, Legal Notice no. 58 of 2020

Food Fortification Regulations, 2020 FOOD FORTIFICATION REGULATIONS, 2020 ARRANGEMENT OF REGULATIONS REGULATIONS PART | - PRELIMINARY 1. Citation 2. Interpretation 3, Application PART Il - COMPETENT AUTHORITIES FOR THE IMPLEMENTATION AND ENFORCEMENT OF THESE REGULATIONS 4. implementing and enforcing Authority PART Ill - FORTIFICATION, PROHIBITION, ADVERTISEMENT, LABELLING, PACKAGING, ETC Food products required to be fortified with micro nutrients Prohibition Advertisement of food products to which no micronutrients have been added Label declaration of food products to which micronutrient have been added Packaging 0. Responsibility of establishments licenced and/or registered to manufacture, process and/or trade in micronutrients and food products fortified with micronutrients 2B O D N A A Part lil~ MISCELLANEOUS 11. Offences and fines 12. Repeal of the Salt lodization Regulations 2005 SCHEDULES SCHEDULE 1- DISEASES, DISORDERS OR PHYSICAL ABNORMAL PHYSICAL STATE SCHEDULE 2- MICRONUTRIENT REFERENCE VALUE (NRVs) SCHEDULE 3- FOOD PRODUCTS FOR WHICH MANDATORY FORTIFICATION IS REQUIRED SCHEDULE 4- CONDITIONS FOR CLAIMS ISSN 0796 -0271 | Supplement “A” to- The Gambia Gazette No. 7¢ of 0th November, 2029 “Legal Notice No. 58 of 2020 REPUBLIC OF THE GAMBIA FOOD SAFETY AND QUALITY ACT, 2011 ACT NO. OF 2011 FOOD FORTIFICATION REGULATIONS, 2020 IN EXERCISE of the power. Section 59 of the Foo Regulations are made. $ conferred on the Vice President under d Safety and Quality Act, 2011, these Food Fortification Regulations, 2020 PART 1 —- PRELIMINARY 1. Citation These Regulations may be cited as Food Fortification Regulations, 2020. 2. Interpretation In these Regulations, unless the content otherwise requires — "Advertising" means the publicity of goods and description of all products which include any form of notices in circulars, hand-outs, labels, wrappers, catalogues and price list, internet media platforms, billboards, posters, newspapers, magazines and any other document made orally or otherwise or by means of projected light and sound recording; “Advertisement” means the publicity of goods and description of all products which include any form of notices in circulars, hand-outs, labels, wrappers, catalogues and price list, internet media platforms, billboards, posters, newspapers, magazines and any other document made orally or otherwise or by means of projected light and sound recording; “Authority” means the Food Safety and Quality Authority of The Gambia; “establishment” means any premises engaged in placing food on the market, including premises where products are prepared, processed (including slaughtered) packaged or stored; “Fortificant" means the prescribed compound which provides the specified micronutrient; "Fortification" means the addition of vitamins, mineral nutrients or amino acids to a food whether or not it is normally contained in the 2 Food Fortification Regulations, 2020 food for the purpose of preventing or correcting a demonstrated deficiency of one or more nutrients in the population; "Fortified Foods" are food products to which vitamins, mineral nutrients or amino acids have been added to for the purpose of preventing or correcting a demonstrated deficiency of one or more nutrients in the population; “Logo” means any symbol authorised by the Authority for use on the packaging or label of certain foods to signify approval by the Competent Authority. "Micronutrient" means a natural or synthesized vitamin, mineral, or trace element that is essential for normal growth, development and maintenance of life and of which a deficit will cause characteristic, biochemical or physiological changes; “Mineral Nutrient" means any of the following chemical elements, whether alone or in a compound form with one or more other chemical elements — (a) calcium: (6) phosphorus: (c) iron; (d) sodium; (e) potassium; (f) iodine; (g) zinc; (n) copper; {i} | magnesium; and (i) manganese: "Nutrient Reasonable Value; NRV" means a set of numerical values that are based on scientific data for purposes of nutrition labelling and relevant claims; "Testimonial" with respect to a food that is represented as contained vitamin, mineral nutrient or an amino acid, means any pictorial, written 3 Food Fortification Regulations, 2020 or oral representation as to the result that is, has been or may be, produced by addition to a person's diet of the vitamin, mineral nutrient or amino acid, as the case may be; "Vitamin" means any of the following vitamins or their synonymous names ~ (a) vitamin A (include retinol and retinal); (b) derivatives excluding carotenes); (c) vitamin B1 or thiamine; (d) vitamin B2 or riboflavine; (e) nicotinic Acid or nicotinamide; (f) vitamin B6 or pyridoxine; (g) folic acid; (h) d-pantothenic acid; (i) biotin: (j) vitamin B12 or cyanocobalamine; {k) vitamin C or L-ascorbic acid: and (i) any salt or derivative of a vitamin listed in paragraph (a) to (j) of these Regulations; "Vitamin A” means any of the following or their synonymous names (a) vitamin A; (b) retinol and retinol derivatives; and (c) any salt or derivative of vitamin A. 3. Application (1) These Regulations shail apply to all fortified food products listed in Schedule Ill of these Regulations that are manufactured, imported, distributed, advertised, sold or used in The Gambia to which micronutrients are added. Food Fortification Regulations, 2020 (2) These Regulations does not apply to food products for export. (3) These Regulations shall apply to organisations or individuals (hereinafter referred to as establishments) licensed or registered to manufacture, process, trade and import micronutrients and food products fortified with micronutrients to meet domestic consumption demands and other agencies, organisations and individuals concerned. PART Il - COMPETENT AUTHORITIES FOR THE IMPLEMENTATION AND ENFORCEMENT OF THESE REGULATIONS 4. Implementing and enforcing Authority (1) The Agency shall be responsible for implementing and enforcing the provisions under these Regulations. (2) In enforcing these regulations, the authority may delegate some of its powers to competent bodies and person. PART Ill — FORTIFICATION, PROHIBITION, ADVERTISEMENT, LABELLING, PACKAGING, ETC 5. Food products required to be fortified with micronutrients (1) Food products listed in Schedule Ill of these Regulations shall be fortified with micronutrients listed in the corresponding national standards. (2) For all fortified food products for which gazetted national standards exist, the requirements of such standards are enforced under these Regulations for conformity assessment. (3) Guidance for voluntary fortification of food products that are fortified for which there are no national developed Standards are provided in Schedule II of these Regulations. 6. Prohibition A person or establishment shall not (a) manufacture, process, import, sell, distribute or advertise any food product that is represented on the label as fortified, enriched or use a terminology as may be applicable with micronutrients unless the particular food product is registered with the Authority; Food Fortification Requlations, 2020 (b) (c) (d) manufacture, process, import, sell, distribute or use food products specified in Schedule Ill to these Regulations, unless it is fortified micronutrients as per the corresponding Gambian Standards referenced in same Schedule of these Regulations; sell or advertise a food product as fortified or enriched with vitamins and minerals, unless the intake of that food product by a person will result in the NRV of more than the quantity of vitamins and mineral nutrients specified in Schedule II to these Regulations; and manufacture, process, import, advertise, sell, distribute, store or use any micronutrient fortified or enriched food product as treatment, preventive or curative, for any diseases, disorders or abnormal physical states specified in Schedule | to these Regulations. 7. Advertisement of food products to which no micronutrients has been added A person or establishment shall not, in advertising a food product to which no micronutrients has been added, label such food product that the food product is — (a) (b) (c) (d) “enriched with” any micronutrient even when the said micronutrient is intrinsic to the product or raw materials thereof; "a source" or "a dietary source" of any of the vitamins and minerals nutrient referred to in these Regulations, if the reference intake of that food by such person is not less than the level as specified in Schedule Il to these Regulations; "a good source” of any of the vitamins and minerals nutrient referred to in these regulations, if the reference intake of that food by a person would result in the daily intake by such person of not less than the amount as specified in schedule II to these Regulations; or an "excellent source" or an "excellent dietary source" or "excellent diet source" of any of the vitamins and mineral nutrient referred to in these Regulations, if the reference intake of that food by a person would result in daily intake by such person of not less than the amount as specified in Schedule II to these Regulations. 6 Food Fortification Regulations, 2020 8. Label declaration of food to which micronutrient has been added (1) Declaration of nutrient should be numerical. However, the use of additional means such as a logo authorized by the Authority shall be acceptable. (2) The vafues used in nutrient declaration shall be weighted average values derived from data specifically obtained from analysis of food products which are representative of the product being labelled. (3) Numerical information on vitamins and minerals shall be expressed in metric units and/or as a percentage of the NRV per 100g or 100ml or per package if the package contains a single portion. In addition, the information may be given per serving as quantified on the Jabe] or per portion provided that the number of portions contained in the package is stated. (4) With the exception of food products listed in schedule III, vitamins and minerals can only be declared if they meet the requirements as stipulated in Schedule |! to these Regulations. (5) The vitamin and mineral content must be at least 5% of the NRV per serving which shall be expressed as a percentage of the NRV per 100g or per 100 ml or per package if the package contains only a single portion and per serving as quantified on the label. (6) When nutrient declaration is applied, unless otherwise stipulated in a relevant Gambian Standard, vitamins and minerals which are present in amounts less than 5% of the NRV per 100 g or 100 mi or per serving as quantified on the Jabe! should not be declared. (7) Notwithstanding Regulation 8, all food products shall comply with the Gambian Standard for the Labelling of Pre-packaged Food (Gams CODEX STAN 1-1985) and any other regulations that shalf be promulgated by the Authority. 9. Packaging Pre-packaged food products fortified with micronutrients shall be — (a) packaged and distributed in a container that shall safeguard the hygienic, nutritional, organoleptic and other qualities of the product: Food Fortification Regulations, 2020 (ob) in a container which the packaging material of the substances are safe and suitable for their intended use; and (c) packaged in a manner that takes into consideration the nature of the fortificant added and its effect on the shelf life of such food product. 10. Responsibility of establishments licensed or registered to manufacture, process or trade in micronutrients and food products fortified with micronutrients It is the responsibility of a food processing, manufacturing, importing, trading or distributing establishment to ensure that (a) their manufacturing, processing, trading and importing of micronutrient and food products fortified with micronutrients comply with provisions of this national regulation and other relevant laws, regulations and standards, (b) they assume liability for their micronutrient products and food products fortified with micronutrients that are not consistent with this regulation, relevant national laws, and standards on food safety. This include ensuring the safety and purity of the micronutrients and their compositions thereof, and {c) micronutrient and food fortified with micronutrient processing establishment must autonomously procure micronutrients for the purpose of manufacturing or processing food products fortified with micronutrients to meet their own demands. PART Ill —- MISCELLANEOUS 11. Offences and Fines (1) A person or establishment who manufacture, process, import, sell, distribute or advertise any food product that is represented on the label as fortified, enriched or any such terminology as may be ~ applicable with micronutrients commits an offence and is liable to a fine of not exceeding one hundred and fifty thousand dalasis. (2) A person or establishment shall manufacture, process, import, sell, distribute or use food products specified in Schedule III to this Regulations, without the fortified micronutrients as per the corresponding Gambian Standards referenced in same schedule of Food Fortification Regulations, 2020 this Regulations commits an offence and is liable to a fine of not exceeding one hundred thousand dalasis. (3) A person or establishment who manufacture, process, import, advertise, sell, distribute, store or use any micronutrient fortified or enriched food product as treatment, preventive or curative, for any of the diseases, disorders or abnormal physical states specified in Schedule [ to these Regulations commits an offence and is liable to a fine of not exceeding one hundred and fifty thousand dalasis. (4) A person or establishment shall not, in advertising a food product to which no micronutrients has been added or on a label of such food, state — (a) that the food is “enriched with” any micronutrient even when the said micronutrient is intrinsic to the product or raw materials thereof; or (6) that the food is “a source" or “a dietary source”, "a good source", “excellent source” or an "excellent dietary source" or "excellent diet source" of any of the vitamins and mineral nutrients referred to in these Regulations, if reference intake of that food product by a person would result in daily intake by such person of not less than the amount as specified in Schedule II to these Regulations, any person or establishment who contravene this section commits and offence and is liable to a fine of not exceeding one hundred and fifty thousand dalasis. 12. Repeal of the Salt lodization Regulation 2005 (1) The Food Fortification and Salt lodization Regulations 2005 is hereby repealed. (2) Notwithstanding the repeal — (a) all act done or purported to have been done under regulations shall not be affected by the repealed regulations; (b) all appointments, or programs made or given under the repealed Regulations, and not inconsistent with these Regulations, shall continue to be in force; and (c) all assets, funds, resources and other moveable property which before the commencement of these Regulations were vested in the Authority shall remain with the Authority. 9 Food Fortification Regulations, 2020 SCHEDULE 1 DISEASES, DISORDERS OR PHYSICAL ABNORMAL 1. Acquired Immune Deficiency Syndrome (AIDS) 2. Corona Virus Disease (COVID) 19 3. Appendicitis Arteriosclerosis Asthma Bloed disorder Cancer o N oO oO fF Cataract 9. Diabetes 10. Cholera 11. Diphtheria 12. Disorder of menstrual flow 13. Disorder of prostate gland 14. Dysentery 15. Encephalitis 16. Enteric fever 17. Epilepsy 18. Erysipelas 19. Filariasis 20. Gall stones, kidney stones and bladder stones 21. Gangrene PHYSICAL STATE 22. Any genital ar urinary diseases not mentioned elsewhere in this schedule 23. Glaucoma 24. Goitre 25. Hay fever 26. Heart disease 27. Hernia 28. High blood pressure 29. infective hepatitis 30. Influenza 31. Jaundice 32. Kidney disease 33. Leprosy 34, Locomotor ataxis 35. Loss of youth 36. Measles 37. Meningitis 38. Mental conditions 39. Mumps 40. Nervousness 41. Nutritional disorders 42. Obesity 43. Onchocerciasis 44, Paralysis 10 45. Plague 46. Pleurisy 47. Pneumonia 48. Poliomyelitis 49, Rabies 50, Rheumatic fever 51. Schistosomiasis 52. Sexual impotence, Loss of virility or Sterility 53. Sleeping sickness 54. Small pox 55. Snake bite 56. Syphilis 57. Tetanus 58. Trachoma 59. Tuberculosis 60. Tumors 61. Typhoid fever 62. Undulant fever 63. Ulcers of the gastro intestinal tract 64. Venereal diseases 65. Yaws 66. Yellow fever 67, Alcoholism Food Fortification Regulations, 2020 SCHEDULE 2 MICRONUTRIENT REFERENCE VALUE (NRVs) Vitamins and Minerals Values Vitamin A 800 (ug) Vitamin D 5 (ug) Vitamin E 9 (mg) Vitamin C nae = 100 (mg) Vitamin B1 (Thiamine) 1.2 (mg) Vitamin B2 (Riboflavin) ; 1.2 (mg) Niacin 15 (mg) Vitamin BS (Pyridoxine) 1.3 (mg) Folic Acid 400 (ug) Vitamin B12 2.4 (ug) Biotin Senusanenall comment 30 (Wg) Pantothenic Acid ik 5 (mg). Calcium 1000 (ug) Vitamin k 60 (yg) Phosphorus — - 700 (mg) Iron 14 (mg) Magnesium 310 (mg) Zinc 11 (mg) lodine | 150 (ug) Copper 900 (jg) Selenium | 60 (ug) Manganese | 3 (ug) Molybdenum 45 (ug) 1i Food Fortification Regulations, 2020 SCHEDULE 3 FOOD PRODUCTS FOR WHICH MANDATORY FORTIFICATION iS REQUIRED | SINO | FOOD VITAMIN, ‘MINERAL NUTRIENT OR AMINO ACID | Pima anenne cia: ——-—-| (i | Wheat Flour | GAMS 18:2018 | i2. | Saft 1 ees |GAMS 20:2018 ——— oo 7 Vegetabie @ oll | GAMS 49: 2048 Mire | Note: unless. otherwise stated, the levels and ranges of micronutrients stated in these standards refers to levels that shall be added in the farms prescribed and shall be enforced as such. It does not include intrinsic levels that are natural to the products. 12 Focd Fortification Regulations, 2020 SCHEDULE 4 CONDITIONS FOR CLAIMS Claim Conditions on food products Source of [Vitamin / Mineral] At least 5% of NRV per 100g/100ml or per serving Good Source of [Vitamin / Mineral] | At least 15% of NRV per 100g (Solids) Or 7.5% of NRV per 100 ml (liquids) Excellent Source of [Vitamin / Mineral] At least 30% of NRV per 100g or 100ml solids & liquids) (at least 2 times the values for “good source of") MADE THIS 2DN DAY OF NOVEMBER 2020 HON. ISATOU TOURAY VICE PRESIDENT