Regulations amending the Regulations relating to the fortification of certain foodstuffs (No. R. 1206 of 2008)

STAATSKOERANT, 14 NOVEMBER 2008 GOVERNMENT NOTICES GOEWERMENTSKENNISGEWINGS DEPARTMENT OF HEAL"rH DEPARTEMENT VAN GESONDHEID No.31584 3 No. R. 1206 14 November 2008 FOODSTUFFS, COSMETICS AND DISINFECTANTS ACT, 1972 (ACT NO. 54 OF 1972) AMENDMENT OF REGULATIONS RELATING TO THE FORTIFICATION OF CERTAIN FOODSTUFFS The Minister of Health has, under section 15(1) of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972), made the regulations in the Schedule. SCHEDULE 1. Definitions In this Schedule, "the Regulations" means the Regulations relating to the Fortification of Certain Foodstuffs, as published in Government Notice No. R. 504 of 7 April 2003. Amendment of regulation 1 of the Regulations 2. Regulation 1 of the Regulations is hereby amended by (a) the insertion after the definition of "the Act" of the following definition: "'Vitamin A' means protected, stabilized vitamin A/retinyl palmitate containing 75 000 mcg RE activity per gram and specifying, on the label of its container, the transport and storage conditions and date up to which the product will comply with the requirements stipulated in Tables 1, 2a, 2b, 3 and 4 of the Regulations." Amendment of regulation 9 of the Regulations 3. Regulation 9 of the Regulations is hereby amended by the substitution for regulation 9 of the following regulation: "9(a) The formulation of the fortification mix for wheat flour, based on the micronutrient requirements specified in Annexure V, Table 4a, shall comply with the minimum levels as follows: TABLE 1: FORTIFICATION MIX FOR WHEAT FLOUR Fortificants and diluent Micronutrient I Fortificant Fortification requirements • requirements mix (per 1 kg II (per 1 kg (g/kg) flour) flour) Vitamin A palmitate1 I (Activity: 75 000 mcg 1 786 mcg I 23,8095 mg 119,0475 RE2/a) RE I Thiamine mononitrate 1,9444 mg I 2,4929 mg 12,4644 (Activity: 78% min.) 4 No. 31584 GOVERNMENT GAZETTE, 14 NOVEMBER 2008 I Riboflavin 1,7778 mg 1,7778 mg 8,8889 • Nicotinamide/ 23,6842 mg I 23,6842 mg 118,4210 niacinamide Pyridoxine HCI 2,6316 mg 3,2489 mg 16,2443 (Activity: 81 % min.) Folic acid 1,4286 mg 1,5786 mg 7,8927 (Activity: 90,5% min.) Electrolytic iron3 35,00 mg 35,7143 mg 178,5714 (Activity: 98% min.) I Zinc oxide I 15,00 mg 18,7500 mg 93,7500 {Activity: 80% min.) Diluent I To complete To complete i 200mg 1 ooo a 1. Protected, stabilized vitamin A palmitate containing 75 000 mcg RE activity per gram. 2. Retinol equivalents (RE) = 1 mcg retinol = 3,33 IU (International units) vitamin A 3. Elemental iron powder where more than 95% passes through a 325 mesh (<45 microns particle size) made by an electrolytic process. (b) The formulation of the fortification mix for maize meal based on the micronutrient requirements specified in Annexure V, Table 4b, shall comply with the minimum levels as follows: TABLE 2a: FORTIFICATION MIX FOR MAIZE MEAL (Super, special, sifted, unsifted) Fortificants and Micronutrient Fortificant Fortification diluent requirements requirements mix (per 1 kg (per 1 kg (g/kg} meal) meal) Vitamin A palmitate 1 (Activity: 75 000 mcg RE2/g) 2 085 mcg RE 27,8000mg 139,0000g Thiamine mononitrate 2,1875 mg 2,8045 mg 14,0224 g (Activitv: 78% min.) Riboflavin 1,6875 mg 1,6875 mg 8,4375 g Nicotinamide/niacinamid 25,000 mg 25,0000 mg 125,0000 g e Pyridoxine HCI 3,1250 mg 3,8580 mg 19,2901 g (Activity: 81% min.) Felic acid 2,0000 mg 2,099 mg 11,0497 g (Activity: 90,5% rr :ii.!ll Electrolytic iron3 35,0000 mg 35,7143 mg 178,6714 g • (Activity: 98% min.) I Zinc oxide . (Activity: 80% min.) 15,00mg 18,7500 mg 93,7500g Diluent To complete To complete - 200mg 1000 g l I i STAATSKOERANT, 14 NOVEMBER 2008 No. 31584 5 1. Protected, stabilized vitamin A palmitate containing 75 000 mcg RE activity per gram. 2. Retinol equivalents (RE) = 1 mcg retinol = 3.33 IU (International units) vitamin A. 3. Elemental iron powder where more than 95% passes through a 325 mesh (<45 microns particle size) made by an electrolytic process." Amendment of regulation 10 of the Regulations 4. Regulation 10 of the Regulations is hereby amended by (a) the substitution for paragraph (b) of the following paragraph: "(b) Where special permission was granted in terms of paragraph (a), the formulation of the fortification mix for unsifted maize meal based on the micronutrient requirements specified in Annexure V, Table 4c, shall comply with the minimum levels as follows: TABLE 2b: FORTIFICATION MIX FOR UNSIFTED MAIZE MEAL (Special permission) I Fortificants and Micronutrient Fortificant Fortification diluent requirements requirements mix (per 1 kg . {per 1 kg (g/kg) meal) meal) Vitamin A palmitate 1 (Activity: 75 000 mcg . 2085mcgRE 27,8000 mg 139,0000 RE2/g) i Thiamine mononitrate 2.1875 mg 2,8045 mg 14,0224 (Activity: 78% min.) Riboflavin 1.6875 mg 1,6875 mg 8,4375 Nicotinamide/niacinamid 25.000 mg 25,0000 mg 125,0000 e Pyridoxine HCI 3.1250 mg 3,8580 mg 19,2901 (Activity: 81% min.) Folic acid 2.0000 mg 2,2099 mg 11,0497 (Activity: 90,5% min.) Electrolytic iron~ 17.5000 mg 17,857 mg 89,2857 · (Activity: 98% min.) Zinc oxide 15.00 mg 18,7500 mg 93,7500 (Activity: 80% min.) Diluent To complete To complete - 200 mg 1000 g l 1. Protected, stabilized vitamin A palmitate containing 75 000 mcg RE activity per gram. 2. Retinol equivalents (RE) = 1 mcg retinol = 3,33 IU (International units) vitamin A. 3. Elemental iron powder where more than 95% passes through a 325 mesh (<45 microns particle size) made by an electrolytic process." (b) by the substitution for paragraph (c) of the following paragraph: http:J\ctl\f!t~Y~rt1.c:..ln 6 No. 31584 GOVERNMENT GAZETTE, 14 NOVEMBER 2008 "(c) The fortification mix shall be used at an addition rate per ton of food vehicle indicated in Annexure VIA: Provided that the final minimum levels in the food vehicle comply with the requirements stipulated in Table 3 and Table 4." Amendment of regulation 11 of the Regulations 5. Regulation 11 of the Regulations is hereby amended (1) by the substitution for (a) paragraph (c) of the following paragraph "(c) The fortification standards referred to in Table 3 and Table 4 of these Regulations shall be the minimum micronutrient levels in uncooked wheat flour and uncooked maize meal when sampled at the point of manufacturing or importation. Amendment of regulation 12 of the Regulations 6. Regulation 12 of the Regulations is hereby amended (1) by the substitution for (a) paragraph (a) of the following paragraph: "(a} the nutrient content claims may be used in addition to the word 'fortified' on one label only in cases where a micronutrient other than the specified fortificants is added to a food vehicle: Provided that the claim complies with the conditions of the specific nutrient content claim;" (b} paragraph (b} of the following paragraph: "(b} the claim 'Fortified for better health' and the official fortification logo to that effect as indicated in Annexure VII are reserved only for food vehicles that have been identified and fortified in accordance with the Regulations and may be displayed on the label or in advertising material;" (c} paragraph (f) of the following paragraph: "(f} the fortification addition rate must be clearly indicated on the label of the fortification mixes;"; and (d) paragraph (g) of the following paragraph: "(g} The label or container of the fortification mix sold as such must indicate the date up to which the product will comply with the requirements stipulated in Table 1, Table 2a and Table 2b of the Regulations." (2) by the insertion after subregulation (I) of the following new subregulation: STAATSKOERANT, 14 NOVEMBER 2008 "{m) Any manufacturer or importer of food vehicles who wishes to be exempted from the provisions of regulations 12 must apply in writing, giving full reasons for the request, to the Director-General for the attention of the Directorate: Nutrition." Amendment of regulation 13 of the Regulations 7. Regulation of the regulations is hereby amended by the insertion after subregulation (5) of the following subregulation: No.31584 7 "(6) Any manufacturer or importer of food vehicles who wishes to be exempted from the provisions of regulation 12 must apply in writing, giving full reasons for the request, to the Director-General for the attention of the Directorate: Nutrition." Amendment of Annexure II of the Regulations 8. Annexure II of the Regulations is hereby amended by the substitution for (a) item 4 of the following item: At least two inspection audits per year, including the taking of samples for laboratory analysis, in respect of all registered fortification mix manufacturers, suppliers and importers, to monitor compliance with the Regulations relating to the Fortification of Certain Foodstuffs shall be conducted at their premises and the manufacturers, suppliers or importers themselves shall bear the costs of such audits and analysis. (b) item 4 of the following item: "4. keep at least one labelled retention sample per batch for the expected shelf-life period"; and Amendment of Annexure Ill of the Regulations 9. Annexure Ill of the Regulations are hereby amended by (a) the substitution for questions 17 and 18 of Annexure Ill of the Regulations of the following questions: "17. Source of vitamin A compound (specify the manufacturers in the case of multiple sources and attach a certificate for each manufacturer): 17.1 Spray-dried vitamin A powder ........................... , 17.2 Oil-based vitamin A .............................. , and 17.3 Spray-dried ......................................... . 18. Source of iron compound (specify manufacturer and attach certificate) (b) the insertion after question 18 of the following question: 8 No.31584 GOVERNMENT GAZETTE, 14 NOVEMBER 2008 "19. Is vitamin A compound stable as per specification? (Attach findings of internal vitamin A stability trials for each source as indicated in question 17)* * For more information on the vitamin A stability specification, contact the Directorate: Nutrition, Department of Health." Amendment of Annexure IV of the Regulations 10. Annexure IV of the Regulations is hereby amended by the insertion after item 7 of the following item: "8. Fortification mix addition rate: g/kg." Insertion of Annexure VIA in the Regulations 11. The following Annexure is hereby inserted after Annexure VI of the Regulations: "ANNEXURE VIA ADDITION RATE OF FORTIFICATION MIXES TABLE 6(e): MAIZE MEAL (super, special, sifted) [Addition rate per ton [maize meal 200 g 300 g 400 g 600g ll ngredient -- G/kg G/kg g/kg I g/kg r Vitamin A palmitate 139,0000 92,6667 46,3333 18,5333 250 000 IU / g . Thiamine mononitrate 14,0224 9,3483 4,6741 1,8697 (Activitv 78% minimum) Riboflavin 8,4375 5,6250 2,8125 1,1250 Niacinamide 125,0000 83,3333 41,6667 16,6667 Pyridoxine HCI (Activity 19,2901 12,8601 6,4300 2,5720 81 % minimum) Folic acid (Activity 98% 11,0497 7,3665 3,6832 1,4733 minimum) I Electrolytic iron 178,6714 I 119, 1143 59,5571 23,8229 (Activity 98% minimum) i Zinc oxide (Activity 93,7500 62,5000 31,2500 12,5000 ' 80% minimum} I Diluent To complete To complete To complete To complete 1000 a 1000 a 1000 a 1000 g TABLE 6(f): UNSIFTED MAIZE MEAL (special permission} 1 Addition rate per ton 200 g 300 g 400 g 600g unsifted maize meal (special permission) Ingredient g/kg G/ka a/ka g/kg Vitamin A Palmitate 139,0000 92,6667 46,3333 18,5333 250 000 \U I a : Thiamine Mononitrate i)i 14,0224 9,3483 4,6741 1,8697 (Activity 78% minimum STAATSKOERANT, 14 NOVEMBER 2008 No.31584 9 Riboflavin 8,4375 5,6250 2,8125 1, 1250 Niacin amide 125,0000 83,3333 41,6667 16,6667 Pyridoxine HCI (Activity 19,2901 12,8601 6,4300 2,5720 81 % minimum) Folic acid (Activity 98% 11,0497 7,3665 3,6832 1,4733 minimum) Electrolytic iron 89,2857 59,5238 29,7619 11,9048 (Activity 98% minimum) I Zinc oxide (Activity 93,7500 62,5000 31,2500 12,5000 80% minimum) / Diluent To complete To complete To complete To complete 1000 a 1000 a 1000 a 1000a TABLE 6(a): WHEAT FLOUR Addition rate per ton 200g 300g 400 g I 500g Wheat Flour Ingredient g/kg Glkg g/kg gtkg Vitamin A palmitate 119,0475 79,3650 39,6825 15,8730 250 000 IU / a Thiamine mononitrate 12,4644 8,3096 4, 1548 1,6619 (Activity 78% minimum' Riboflavin 8,8889 5,9259 2,9630 1, 1852 Niacin amide 1184210 1 78,9473 39.4737 15,7895 Pyridoxine HCI (Activity 16,2443 10,8295 5,4148 2,1659 81 % minimum) Folic acid (Activity 98% 7,8927 5,2618 2,6309 1,0524 minimum) Electrolyttc k"on 178,5714 119,0476 59,5238 23,8095 (Activity 98% minimum' Zinc oxide (Activity 93,7500 62,5000 31,2500 12,5000 80% minimum) Diluent To complete To complete To complete To complete I 1000 g 1000 g 1000 g 1000 g I ·~ MSB HOGA ' MP MINISTER OF HEAL TH G0B-104050-B