Food Fortification Regulations 2021. S.I. no. 67 of 2021

Extraordinary Federal Republic of Nigeria Official Gazette No. 135 Lagos—17th August, 2021 Vol. 108 Government Notice No. 109 The following is published as Supplement to this Gazerte : S. I. No. Short Title Page 67 Food Fortifications Regulations, 2021... 0. 0. .- B3091-3108 Printed and Published by The Federal Government Printer, Lagos, Nigeria FGP 157/09202 1/150 Annual Subscription from Ist January, 2021 is Local : N45.000.00 Overseas : N60.500.00 [Surface Mail] N75.000.00 [Second Class Air Mail]. Present issue N3.000 per copy. Subscribers who wish to obtain Gazette after Ist January should apply to the Federal Government Printer, Lagos for amended Subscriptions. nage, > <fe8 egiqan oR He 335 OV SOK Mss ideser 2} settles gitad ert] a B 3091 NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL ACT (CAP. N1 LEN), 2004 FOOD FORTIFICATION REGULATIONS, 2021 Regulation : 1. Ww N O 10. 12. [3. 14. S O S OY | O Y Scope of application. Prohibition. Advertisement of foods to which no Vitamin or Mineral has been added. Label declaration of food to which Vitamin or mineral has been added. Statement relating to mineral content of food. Label declaration of food mandatorily fortified with Vitamin A. Labelling. Packaging. Offences and Penalties. Forfeiture after conviction. Revocation. : Enforcement of these Regulations. Interpretation. Citation. SCHEDULES B 3093 S. I. No. 67 of 2021 NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL ACT (CAP. Ni, LFN), 2004 FOOD FORTIFICATION REGULATIONS, 2021 [7th Day of July, 2021] Commence ment. In exercise of the powers conferred on it by sections 5 and 30 of the National Agency for Food and Drug Administration and Control Act (Cap. N1, LFN) 2004 and section 12 of the Food, Drug and Related Products (Registration, Etc.) Act (Cap. F33, LFN) 2004 and all other powers enabling it in that behalf, the Governing Council of the National Agency for Food and Drug Administration and Control with the approval of the Minister of Health makes the following Regulations— 1. These Regulations shall apply to all fortified foods manufactured, Scope of imported, exported, distributed, advertised, sold or used in Nigeria. application. 2.—(1) A person shall not— Prohibition. (a) sell or advertise any food that is represented on the label to the general public as fortified with vitamins and mineral unless it is registered with the Agency ; (6) manufacture, import, export, advertise, sell, distribute, store or use any fortified food as treatment, preventive or curative for any of the diseases, disorders or abnormal physical states specified in the First Schedule to these Regulations ; (c) sell or advertise any food to the general public as fortified with vitamins and minerals referred to in these Regulations, where the Nutrient Reference Value (NRV) intake of that food by a person will result in the NRV by such a person of more than the quantity of vitamins and mineral nutrients specified in Second Schedule to these Regulations ; (d) in the case of the foods specified in Fourth Schedule to these Regulations, manufacture, import, export, sell, distribute or use, unless it is fortified with vitamin A as prescribed by the Agency. (2) Food product for the purpose of Global Listing for supermarket items and restaurant operators, shall not be allowed unless it complies with the provisions of these Regulations or as prescribed by the Agency. (3) Only foods listed in Fifth Schedule to these Regulations maybe fortified with the corresponding vitamins or minerals as specified in the same Schedule. 3. A person shall, in advertising a food to which no vitamin or mineral — Advertise content has been added or on a label of such food, state— ment of foods to (a) that the food is “a source” or “a dietary source” of any of the \hich no vitamins and mineral nutrient referred to in these Regulations, where Vitamin or reference intake of that food by such person is not less than the level Mineral has specified in Second Schedule to these Regulations ; REpH ARIES, duslitia revs. pane we init estat 23 nl >. tisaetiy duister ns dodt-we Tes ~~ apg A (ya RA 7 Sigiarl Lot Sit ni intastg A mmall! sar to imines eiviny Sabbe a ~ -- “SISrhais> ahase Tr hare ae VRSp 4 i ee Seer sit Ss ee : * aeoipugay Best B 3094 declaration of food to which Vitamin or mineral has been added. Statement relating to content of food. of food mandatorily fortified with Vitamin A. (5) that the food is “a good source” of any of the vitamins and minerals nutrient referred to in these Regulations, where 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 Second Schedule to these regulations ; or (c) that the food is 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, where 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 the Second Schedule. 4.—(1) Aperson shall not sell a food to which a vitamin has been added unless the amount of the vitamin present in the food is expressed on the label of the food. (2) Vitamins and minerals can only be declared where they meet the requirements as stipulated in the Second Schedule to these Regulations. (3) The vitamin and mineral content shall be at least 5% of the NRV per serving, which shall be expressed as a percentage of the NRV per 100g or per 100ml or per package, where the package contains only a single portion and per serving as quantified on the label. (4) Where vitamins or minerals are present in significant amounts of 15% or higher per serving of food, the conditions in order to qualify for the claim with the prescribed wording for claims shall be provided in Sixth Schedule to these Regulations. (5) Where nutrient declaration is applied, vitamins and minerals, which are present in amounts less than 5% of the Nutrient Reference Value per 100g or 100ml or per serving as quantified on the label shall not be declared. 5. Where the amount ofa mineral nutrient referred to in these Regulations is contained in a food is not less than the amount mentioned in the Second Schedule to these Regulations, in advertising that food or on a label of that food, it shall state— (a) in the case of calcium or phosphorous, that it is a factor in the normal development and maintenance of bones and teeth, especially in infants and children ; and (5) in the case of calcium, phosphorous or iron, that it is a factor in the maintenance of good health. 6.—(1) A person shall not sell any food, to which vitamin A has been added, unless the amount of the Vitamin A present in the food is expressed on the label of the food and in the quantity as provided in Second Schedule to these Regulations. (2) Mandatory food fortification with vitamin A shall be as prescribed in Third Schedule to these Regulations. (3) Flour when fortified, shall contain the micronutrient as provided in the Fourth Schedule to these Regulations. 7. In addition to complying with the Agency’s Pre-packaged Food, Water and Ice Labelling Regulations, the following shall apply, the— (a) amount of vitamin or mineral nutrient added to the specific quantity of the food shall be declared as percentage daily value on the product label ; and (b) products stated in Second Schedule shall carry on their label a picture of an eye with A at the centre of the eye to indicate they are fortified with Vitamin A. 8.—(1) Pre-packaged food fortified with vitamin and mineral nutrients shall be packaged and distributed in container that shall safeguard the hygienic, nutritional, organoleptic and other qualities of the product. (2) The container, including packaging material, shall be made of substances, which are safe and suitable for their intended use. (3) All fortified food shall be packaged in a manner that takes into consideration the nature of the fortificant added and its effect on the shelf life of such food. 9.—({1) Any person who contravenes any of the provisions of these Regulations commits an offence and liable on conviction, in the case of — (a) an individual, to imprisonment for a term not exceeding 1| year or to a fine not exceeding N800,000.00 or to both ; and (b) a body corporate, to a fine not exceeding N5,000,000.00. (2) Where an offence under these Regulations is committed by a body — corporate, firm or other association of individuals every— (a) director, manager, secretary or other similar officer of the body corporate ; (5) partner or officer of the firm ; (c) trustee of the body concerned ; (d) person concerned in the management of the affairs of the association ; or (e) person who purports to act in a capacity referred to in paragraphs (a) to (d) of this sub-regulation, is severally liable to be proceeded against and punished for the offence in the same manner as if the person committed the offence, unless the person proves that the act or omission constituting the offence took place without his knowledge, consent or connivance. B 3095 Labelling. Offences and Penalties. B 3096 Forfeiture after conviction. Revocation. Enforcement of these Regulations. Interpretation. 10. A person convicted of an offence under these Regulations shall forfeit to the Federal Government— (a) any asset or property constituting proceeds derived from or obtained, directly or indirectly, as a result of the offence ; and (b) any of the person’s property or instrumentalities used in any manner to commit or to facilitate the commission of the offence. 11.—(1) The Food Fortification Regulations 2005 and Vitamin A Fortification Regulations 2005 are revoked. (2) The revocation of the Regulations Specified in sub-regulation (1) of this regulation shall not affect anything done or purported to be done under the revoked Regulations. 12. The Agency shall be responsible for the enforcement of these Regulations. 13. In these Regulations— “Advertising” means the publicity of goods and description of all products which include any form of notices in circulars, handouts, labels, wrappers, catalogues and price list, 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, handouts, labels, wrappers, catalogues and price list, billboards, posters, newspapers, magazines and any other document made orally or otherwise or by means of projected light and sound recording ; “Agency” means the National Agency for Food and Drug Administration and Control ; “Food” means any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drinks, chewing gum and any substance which has been used in the manufacture, preparation or treatment of “food” but does not include cosmetics or tobacco or substances used only as drugs ; “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 food for the purpose of preventing or correcting a demonstrated deficiency of one or more nutrients in the population groups ; “Fortified Foods” are foods 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 groups ; “Global Listing” means a scheme that enables the importation of conventional food and cosmetics items by supermarket operators for retail purposes within approved outlets. Approvals will be granted annually for restricted quantities ; “Logo” means any symbol authorized by the Agency for use on the packaging or label of certain foods to signify approval by the Government ; “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 with one or more other chemical elements : (a) calcium, (6) phosphorus, (c) iron, (d) sodium, (e) potassium, (f) iodine, (g) zinc, (h) copper, (i) magnesium, and (7) manganese ; “Nutrient Reference Value (NRV)” means a set of numerical values that are based on scientific data for purposes of nutrition labeling and relevant claims; “Proceeds” means any property derived or obtained, directly or indirectly, through the commission of the offence ; “Testimonial” with respect to a food that is represented as contained vitamin, mineral nutrient or an amino acid, means any pictorial, written 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 retinol derivatives), (b) derivatives excluding carotenes), (c) vitamin B1 or thiamine, (d) vitamin B2 or riboflavin, B 3097 B 3098 (e) nicotinic Acid or nicotinamide, (f) vitamin B6 or pyridoxine, (g) folic acid, (h) d-pantothenic acid, (1) biotin, (/) vitamin B12 or cyanocobalamine, (k) vitamin C or L-ascorbic acid, and (/) any salt or derivative of a vitamin listed in paragraph (qa) to (/) of this regulation ; and “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. Citation. . 14, These Regulations may be cited as Food Fortification Regulations, 2021. N N N S R R R R RP R e e N E S S R A A A R G H S 23. 24. 23. 26. 21. 28. 29. 30. 31. 32. 33. 34. 3): 36. Sis 38. ao. 40. 41, 42. S O R N A N R W N First SCHEDULE [Regulation 2 (1) (6)] Acquired Immune Deficiency Syndrome ; Alcoholism ; Appendicitis ; Arteriosclerosis ; Asthma ; Blood disorder ; Cancer ; Cataract ; Diabetes ; Cholera ; Diphtheria ; Disorder of menstrual flow ; Disorder of prostate gland ; Dysentery ; Encephalitis ; Enteric fever ; Epilepsy ; Erysipelas ; Filariasis ; Gall stones, kidney stones and bladder stones ; Gangrene ; Any genital or urinary diseases not mentioned elsewhere in this schedule ; Glaucoma ; Goiter ; Hay fever ; Heart disease ; Hernia ; High blood pressure ; Infective hepatitis ; Influenza ; Jaundice ; Kidney disease ; Leprosy ; Locomotor ataxis ; Loss of youth ; Measles ; Meningitis ; Mental conditions ; Mumps ; Nervousness ; Nutritional disorders ; Obesity ; B 3099 B 3100 43. 45. 47. 48. 49. 50. Al ae: a3. 34. a5. 56. a1. 58. 59. 60. 61. 62. 63. 65. 66. Onchocerciasis ; Paralysis ; Plague ; Pleurisy ; Pneumonia ; Poliomyelitis ; Rabies ; Rheumatic fever ; Schistosomiasis ; Sexual impotence, Loss of virility or Sterility ; Sleeping sickness ; Small pox ; Snake bite ; Syphilis ; Tetanus ; Trachoma ; Tuberculosis ; Tumors ; Typhoid fever ; Undulant fever ; Ulcers of the gastro-intestinal tract : Venereal diseases ; Yaws ; and Yellow fever. [Regulation 2 (1) (c), 3 (a) and (c), 4 (2), 5 (1), 6 (¢) and 7 (b)] SECOND SCHEDULE NUTRIENT REFERENCE VALUES (NRVS) Vitamins and Minerals Values Vitamin A 800 (1g) Vitamin D 5 (ug) Vitamin E 9 mg Vitamin C 100 (mg) Vitamin B1 (Thiamine) 1.2 (mg) Vitamin B2 (Riboflavin) 1.2 (mg) Niacin 15 (mg) Pyridoxine (B,) 1.3 (mg) Folic Acid 400 (ug) Vitamin B,, 2.4 (ug) Biotin 30 (ug) Pantothenic Acid 5 (mg) Calcium 1000 (ug) Vitamin k 60 (ug) Phosphorus 700 (mg) Iron 14 (mg) . Magnesium 310 (mg) Zinc 11 (mg) Iodine ~ 150 (ug) Copper 900 (ug) Selenium 60 (1g) Manganese 3 (pg) Molybdenum 45 (ug) B 3102 THIRD SCHEDULE [Regulations 6] LEVELS OF MANDATORILY FORTIFIED FOODS WITH VITAMIN A Vehicle Level of Fortificant Sugar 25,000 iu/kg Wheat and Maize Flour 6000 iu/kg Vegetable Oil 20,000 iu/kg Margarine & Butter 26,000 — 33,000 iu/kg B 3103 FOURTH SCHEDULE [Regulation 2 (1) (c) and 6 (2)] MANDATORY MICRONUTRIENTS REQUIREMENTS FOR WHEAT FLOUR, COMPOSITE FLOUR, MAIZE FLOUR, WHEAT SEMOLINA AND WHOLE MAIZE MEAL VitaminA |Dry vitamin A palmitate250 CWS/SN/CWD 2.0 mg/kg Vitamin B9 | Folic acid Food grade 2.6 mg/kg Vitamin B12}0.1% CWS/SN/CWD 0.02 mg/kg Tron NaFeEDTA (anhydrous in line with FCC) 40.0 mg/kg Vitamin B2 | Riboflavin Fine powder 5.0 mg/kg Zinc Zinc oxide 50.0 mg/kg Vitamin B1 | Thiamine Mononitrate 6.0 mg/kg Vitamin B3 | Niacinamide 45.0 mg/kg Vitamin B6 | Pyridoxine Hydrochloride 6.0 mg/kg B 3104 FIFTH SCHEDULE FOOD TO WHICH A VITAMIN, MINERAL, NUTRIENT OR [Regulation 2 (3)] AMINO ACID MAY BE ADDED S/No Food Vitamin, Mineral Nutrient or Amino Acid Breakfast Cereals Voluntary: Thiamine, niacin, vitamin B6, folic acid, pantothenic acid, magnesium, iron, zinc Fruit nectars, fruit drinks and bases concentrates mixes for fruit drink and a mixture of vegetable juices Voluntary: Vitamin C Infant Cereal Products ® Voluntary: Thiamine, riboflavin, niacin or niacinamide, calcium, phosphorus, iron, iodine Margarine and other similar substitutes for butter. Mandatory: Vitamin A, vitamin D Voluntary: Alpha-tocopherol Alimentary Pastes Voluntary: Thiamine, riboflavin, niacin or niacinamide, folic acid, pantothenic acid, vitamin B6, iron, magnesium Enriched Alimentary Pasta Mandatory: Thiamine, riboflavin, niacin, folic acid, iron Voluntary: Pantothenic acid, vitamin B6, magnesium Prepared infant formulas and formulated liquid diet Vitamins - Alpha-tocopherol, biotin, dpantothenic acid, folic acid, niacin, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin K Minerals - calcium, chloride, copper, chromium, iodide, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc ; Amino Acids - alanine, arginine, aspartic acid, cystine, glutamic acid, glycine, histidine, hydroxyproline, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine (to improve the quality of the protein) Also - other nutritional substances at the same levels found in human milk (for infant formula) Food represented for use in a very low-energy diet Mandatory: Vitamins - Alpha tocopherol, biotin, d-pantothenic acid, folic acid, niacin, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin K Minerals - Calcium, chloride, chromium, copper. iodine. iron, magnesium, manganese. molybdenum, phosphorus, potassium, selenium, sodium, zinc Flavoured beverage mixes and bases recommended for addition to milk Voluntary: Vitamin A, thiamine, niacin or niacinamide, vitamin C, iron. 10. Simulated meat products, simulated poultry meat products, meat product extenders and poultry product extenders Mandatory: Thiamine, riboflavin, niacin, pyridoxine, d-pantothenic acid, folic acid, vitamin B12, iron, magnesium, potassium, zinc, copper Amino Acids - Histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine Meal replacements and nutritional supplements Mandatory: Vitamins — alpha tocopherol, biotin, d-pantothenic acid, folic acid, niacin, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D Minerals — calcium, chloride, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc 12. Ready breakfast, instant breakfast and other similar breakfast replacement foods however described Mandatory: Vitamin A, thiamine, riboflavin, niacin or niacinamide, vitamin C, iron. B 3105 B 3106 13. Milk, milk powder, sterilized milk, (naming the flavour) milk Voluntary: Vitamin D 14. Condensed milk Voluntary: Vitamin D is: Skim milk with added milk solids, partly skimmed milk with added milk solids, (naming the flavour) skim milk, (naming the flavour) partly skimmed milk, (naming the flavour) skim milk with added milk solids, (naming the flavour) partly skimmed milk with added milk solids, skim milk, partly skimmed milk, skim milk powder Voluntary: Vitamin A, vitamin D 16. Evaporated skim milk, concentrated skim milk, evaporated partly skim milk, concentrated partly skimmed milk Voluntary: Vitamin A, vitamin C, vitamin D 17. Evaporated Milk Voluntary: Vitamin C, Vitamin D 18. Apple juice, reconstituted apple juice, grape juice, reconstituted grape juice, pineapple juice, reconstituted pineapple juice, apple and (naming the fruit) juice concentrated fruit juice except frozen concentrated orange juice Voluntary: Vitamin C 19. Apple juice, reconstituted apple juice, grape juice, reconstituted grape juice, pineapple juice, reconstituted pineapple juice, concentrated fruit juice. Vitamin C. 20. Enriched flour Garri, yam flour and other cereals flour Mandatory: Thiamine, riboflavin, niacin, folic acid, iron Voluntary: Vitamin B6, d- pantothenic acid, calcium, magnesium 21. Salt, table salt Mandatory lodine (in the form of potassium iodide). 22. Sugar Mandatory Vitamin A 23. Vegetable oil Mandatory Vitamin A B 3107 B 3108 SIXTH SCHEDULE [Regulation 4 (4)] CONDITIONS FOR CLAIMS Claim Conditions on food Source of (Vitamin and Mineral) At least 5% of NRV per 100g/100ml or per serving Good Source of (Vitamin and 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”) Maoe at Abuja this 7th day of July, 2021. Dr. OsaaieE E. EHANIRE, MD, FWACS Honourable Minister of Health