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Government  notices  • G oewermentskennisGewinGs
Health, Department of/ Gesondheid, Departement van
217 F oodstuffs, Cosmetics and Disinfectants Act (54/1972): Regulations relating to the Fortification of Certain Food-
stuffs  ........................................................................................................................................................................  39776  4Page
No.Gazette
No. No.ContentsFOODSTUFFS, COSMETICS AND DISINFECTANTS ACT, 1972(ACT NO. 54 OF 1972)
REGULATIONS RELATING TO THE FORTIFICATION OF CERTAIN FOODSTUFFS
The Minister of Health has, under Section 15(1) of the Foodstuffs, Cosmetics andDisinfectants Act, 1972 (Act No. 54 of 1972), made the regulations in the Schedule.
Interested persons are hereby invited to submit written comments on the proposedamendments to the Director-General: Health, Private Bag X828,Pretoria, 0001 (for theattention of the Director Nutrition), within three months from the date of publication of thisNotice.
SCHEDULE
Definitions1.in these Regulations any word or expression defined in the Act bears the samemeaning as in the Act and unless the context otherwise indicates-
"Department" means the National Department of Health;
"diluent" means a suitable, inert, food-grade carrier for the micronutrients;
"food vehicle" means dry and uncooked wheat flour, dry and uncooked maize meal,precooked maize meal and, bread prepared with and containing at least 90% fortified wheatflour (including brown bread flour), excluding water;
"fortificant" means the prescribed compound which provides the specified micronutrient;
"fortification mix" means a premixed blend of fortificants and diluents formulated to providespecified and determinable amounts of micronutrients;
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Government  notices  • G oewermentskennisGewinGs
Health, Department of/ Gesondheid, Departement van
DEPARTMENT OF HEALTH
NO. 217  
 03 MARCH 20
16
217 F oodstuffs, Cosmetics and Disinfectants Act (54/1972): Regulations relating to the Fortification of Certain Foodstuffs   3977 6
"fortification" means the addition of one or more micronutrients by means of a fortificationmix to a foodstuff whether or not it is normally contained in a foodstuff for the purpose ofpreventing or correcting a demonstrated deficiency of one or more nutrients in the generalpopulation or specific population group of South Africa as determined by the Department;
"highly fortified maize meal or maize flour" means maize meal or maize flour that havebeen fortified at levels of at least 30% of the Nutrient Reference Values of individuals olderthan 36 months of age, as required for nutrient content claims in the Regulations relating tothe Labelling and Advertising of Foodstuffs.;
"maize meal" means all milled, uncooked maize products and includes super, special, siftedand unsîfted maize meal and precooked maize meal, but excludes samp, grits, maize riceand maize flour and maize meal certified organic according to the latest Codex Alimentariusstandards and packed in quantities not larger than lkg;
"thicronutrienf means a natural or synthesised vitamin, mineral, or trace element that isessential for normal growth, development and maintenance of life and of which a deficit willcause characteristic biochemical or physiological changes;
"precooked" means maize meal which has undergone further processing following the mainmilling process in such a manner as to enable it to be prepared for consumption using limitedor no additional cooking;
"quality control" means the measures applied and the steps taken by a manufacturer ofwheat flour, maize meal, maize flour or fortification mixes to ensure that the correctprocedures are being followed and the set criteria are being met in the manufacturing and
distribution of fortification mixes or the administering of fortificants to wheat flour, maize mealor maize flour;
"SANAS" means the South African National Accreditation Services as defined in theRegulations relating to the Labelling and Advertising of Foodstuffs;
"the Act" means the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of1972);
"the Regulations relating to the Labelling and Advertising of Foodstuffs" means theRegulations relating to the Labelling and Advertising of Foodstuffs (Government Notice NoR. 146 of 1 March 2010), made under section 15 of the Act;
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"Vitamin A" means protected, stabilized vitamin A/retinylpalmitate containing 75 000 mcgRE activity per gram and specifying, on the label of its container, the transport and storageconditions and date up to which the product will comply with the r uirements stipulated inTables 1, 2, 3, 4,5, of the Regulations;
"wheat bd" means all baked bread prepared with and containing at least 90% fortifiedwheat flour excluding water;
"wheat flour" means the following milled, dry and uncooked wheat products as defined inthe Regulations relating to the grading, packing and marking of wheat products intended forsale in the Republic of South Africa, 2008 (Government Notice No. R.186 of 22 February2008) made under section 15 of the Agricultural Products Standards Act,1990 (Act No. 119of 1990), but excludes crushed wheat, pearled wheat, semolina, stabilised wheat productsand wheat flour certified organic according to the latest Codex Alimentarius standards andpacked in quantities not larger than 1 kg :(a)Brown bread wheat flour;(b)cake wheat flour;(c)high bran wheat flour;(d)industrial wheat flour;(e)self-raising wheat flour;(f)soft wheat flour;(g)whole wheat brown flour; and(h)whole wheat flour.
General provisions
2,(1) Any person who manufactures, imports or sells foodstuffs identified as food vehicleswhich have not been fortified inaccordance with these Regulations, including therequirements specified in Annexure B, shall be guilty of an offence.
(2)Any person who manufactures, imports or sells maize meal or maize flour, maymanufacture; import or sell highly fortified maize meal or maize flour provided it meets theminimum levels specified by the requirements of these regulations for such a foodstuff.
(3)Any person who manufactures, imports or supplies a fortification mix for the purpose ofthese Regulations, without being registered with the Department, including the requirementsspecified in Annexure C, shall be guilty of an offence.
(4)A person desiring to manufacture, import or supply a fortification mix shall apply to the
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Director-General for registration by submitting the information specified Annexure D.
(5)The registration referred to in subregulati (4) is valid for a period of one year.
(6)Registered manufacturers, importers or suppliers of rtifiion mixes
(a)comply with the principles set out in Annexure C; and
(b)issue a certificate of compliance as indicated in Annexure E.
(7)Manufacturers and importers of food vehicles or highly fortifiedmaize meal or maizeflour-
(a)may only obtain the fortification mix from companies that have registered with theDepartment; and
(b)shall keep on record a certificate of compliance for every batch of fortification mixin the format specified in Annexure IV.
Special provisions
a)The formulation of the fortification mix for wheat flour shall comply with theminimum levels indicated in Annexure A, Table 1.
(b)The formulation of the fortification mix for maize meal shall comply with the
minimum levels indicated in Annexure A, Table 2.
(c)The formulation of the fortification mix for maize meal or maize flour that is highlyfortified shall comply with the minimum levels indicated in Annexure A. Table 3*
(ci)The fortification of wheat flour containing wheat bran must allow for the additionof the fortification mix to the base flour.
(e)The fortification mix shall be used at an addition rate per tan of food vehicleindicated in Annexure F.
(2)(a)Additives and flavourants used in the manufacturing of highly fortified maize mealor maize flour shall be in accordance with additives and flavourants permitted inthe Act.
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(b)Manufacturers of fortified food vehicles or highly fortified maize meal or maizeflour, will be audited by an Inspector for compliance with the requirements ofthese regulations as indicated in Annexure B.
Labelling of fortified foodstuffs
4.In addition to the Regulations relating to the Labelling nd Advertising of Foodstuffsall food vehicles shall be labelled as follows:
(a)The nutrient content claims may be used in addition to the word 'fortified on alabel only in cases where a micronutrient other than the specified fortificants isadded to a food vehicle, provided that the claim complies with the conditions ofthe specific nutrient content claim criteria based on SANAS accredited laboratoryanalyses.
(b)The claim 'Fortified for better health' and the fortification logo to that effect asindicated in Annexure G are reserved only for food vehicles that have beenidentified and mandatory fortified in accordance with the Regulations and may be
displayed on the label or in advertising material,
(c)Any person who uses the official logo referred to in Annexure H on labels or inadvertisingmaterialforfoodstuffsother thaninaccordance withtheseRegulations or any other regulations made in terms of the Act, shall be guilty ofan offence.
(d)(i)The claim "Manufactured with fortified maize meal for better health" or"Manufactured with fortified wheat flour for better health", whatever the
case may be, may be used for foodstuffs, other than food vehicles,prepared with and containing at least 90% of one or more of the identifiedfood vehicles as ingredient, excluding water;(ii)A logo as indicated in Annexure H may be displayed on the label or at thepoint of sale on a notice displayed in the direct vicinity of where thefoodstuff referred to in subparagraph (i) is displayed on the shelf and withinclear sight of the consumer.
(e)Minerals of the fortification mix shall-
(i)in the list of ingredients be identified individually by the compound names(for example NaFeEDTA, ferrous fumarate, zinc oxide); and
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(f)(ii)indicate the elemental mineral in the table with nutritional information.
The design of the logo accompanying the claim 'fortified for better health' or theclaim 'manufactured with fortified wheat flour for better health' or 'manufacturedwith fortified maize meal for better health' shall be constructed as indicated infacsimile 1 in Annexure G or Annexure H.
(g)Where the full colour version of the logo accompanying the claims 'fortified forbetter health', 'manufactured with fortified wheat flour for better health or'manufactured with fortified maize meal for better health' is used, the followingcolours shall be used in accordance with facsimile 2 in Annexure F or AnnexureH:
Grass:GreenIPantone 390(45c100y)
Male's shorts:Green 2Pantone 349(100c100y54k)
Sun:Orange 1 Pantone 123 (28m100y)
Back female's arms x 2, legs x 2, head:Orange 2 Pantone 138 (53m100y 8k)
Back female's skirt, front female's eyes x 2:Blue 1Pantone 3015
Front female's T-shirtBlue 2Pantone 274
Sky :Blue 3Pantone 290(100o
(100c
(10e)40k)
100m30k)
Front female's arms x 2, legs x 2, head :FleshPantone 719(15m18y)
Male's T-shirt:YellowProcess yellow(100y)
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Male's arms x 2, legs x 2, head:BrownPantone 470(56m78y40k)
Back female's T-shirt, mouth, front female's skirt and mouth:RedPantone 485(100m 100y)
Male's hair, ey.,x 2, mouth, back female's hair, eyes x 2, front female'shair, outer circular border, all payoff lines:BlackProcess black
(h)The claim "Highly fortified" and accompanying logo may only be used for foodvehicles complying with the requirements of Table 6 of these Regulations andshall be constructed as indicated in Annexure I.
(i)The fortification logos shall be printed in a prominent position on The main panelin bold print against a contrasting or clear background on all types of packagingmaterial. The logos shall be clearly visible, easily legible and indelible.
(j)The fortification logos may be printed in monochrome as per facsimile 1 inAnnexure G or Annexure Hot' Annexure I or in any of the selected main colours ofthe packaging.
(k)The official logo shall be a minimum size of 35 mm for bread. The size of thefortification logos for maize meal, wheat flour, highly fortified maize meal or maizeflour shall be as follows
(I)Weight (kg)
1 kg2- 6 kg- 24 kga 25 kgSize of fortificationlogos25 mm35 mmSO mm100 mm
In addition to the requirements of these Regulations and the Regulations relatingto the Labelling and Advertising of Foodstuffs made under the Act, the label ofhighly fortified maize meal or maize flour should comply with the labellingrequirements of the Regulations relating to Foodstuffs for Infants and YoungChildren made under the Act.
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Labelling of fort'cation mixes
5.(1) In addition to the requirements of the Regulations relating to the Labelling andAdvertising of Foodstuffs made under the Act, the label or container of the fortificationmix sold as such must indicate the date up to which the product will comply with therequirements stipulated in Table 1, Table 2 and Table 3 of Annexure A of theregulations when stored under the fortification mix manufacturers, suppliers orimporters recommended conditions.
(2)The fortification addition rate must be clearly indicated on the label of the fortificationmixes referred to in Table 1, Table 2 and Table 3 of Annexure A of these Regulations.
Delegations
6.(1) The Director-General may, subject to such conditions as she or he may determine, inwriting, in general, in a particular case or in cases of a particular nature delegate, to any
officerin the Department any power conferred upon her or him by or under theseRegulations.
(2)The Director-General shall not be divested of a power delegated by her or him undersubregulation (1), and may alter or set aside any decision by an officer taken in the exerciseof a power so delegated.
Repeal
7.The Regulations published under Government Notice No. R. 504 of 7 April of 2003 asmend:.by Government-Notice No. R. 1206 of 14 November of 2008, are hereby repealed.
DROALEDI, MPOF HEALTHLu,
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ANNEXURE A
FORTIFICATION MIX
TABLE 1
FORTIFICATION MIX1 FOR WHEAT FLOUR
Fortificants and diluent2MillifTIUMrnicronutrientrequirements(per 1 kg flour)Minimummicron utrientrequirement(per 1 kgfortificationmix)Minimumfortificantrequirementig/kg fortificationmix)
Vitamin A palmitate(Activity: 75 000 mcg RE3/9) 1786 mcg5953 mg79 38 g
Thiaminmononitrate(Activity: 81% minimum) 1.94 mg6.47 g7.98 g
Riboflavin(Activity: 100% minimum) 1.77 mg5.9 g5.90 g
Nicotinamide/nlacinamide(Activity: 99% minimum)223.7 mg79.0 g79.80 g
Pyridoxine MCI(Activity: 82% minimum) 2 ,63 mg8.77 g10.69 g
Folicacid(Activity: 90.5% minimum) 1.43 mg4.77 g5.27 g
Cyanocobalamin (water soluble)(Activity: 0.1% minimum)4 0.005 mg 0.017 g 16.67 g
NaFeEDTA(Activity: 13% minimum) 5 15.0 mg50.0 g384.62 g
Zinc oxide(Activity: 80% minimum) 30,0 mg100.0 g125.0 g
Diluent To complete1000 g
Notes1.Based on a dosage rate of 300 g per metric tonne (300 g/MT) dosage. Adjustment ofthe dosage rate should comply with the relevant minimum requirements indicated inTable 4. Annexure V.2.Fortificante and diluents should pass through a 212 um sieve.
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3.Retinol equivalents (RE) = i meg retinol = 3,33 lU (International units) vitamin A.4,Use of I% eyanoeobalamin is permitted with suitable adjustment of the fortification mixformulation.NaFeEDTA shall comply with the requirements given in the latest edition of the FoodChemicals Codex,
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TABLE 2
FORTIFICATION MIX' FOR MAIZE MEAL(Super, special, sifted, unsifted, precooked)
Fortificants and dituent2Minimummicronutrientrequirements(per 1 kg maizemeal)Minimummicronutrientrequirement (per1 kg fortificationmix)Minimumfortiflcantrequirement(g/kgfortification mix)Vitamin A palmìtate3(Activity: 75 000 mcgRE/g) 2090mcg6950 mg92.67 g
Thiaminmononitrate(Activity: 81% minimum) 2.19 mg7.30 g9.01 g
Riboflavin(Activity: 100%minirnum) 1.69 mg5.63 g5.63 g
Nicotinamideiniacinamide(Activity: 99% minimum) 25.0 mg283.33 g84,18 g
Pyridoxine HCI(Activity: 82% minimum) 3.13 mg10.43 g12.72 g
Folicacid(Activity: 90.5% minimum) 2.0 mg6.67 g7.37 g
Cyanocobalamin (watersoluble)(Activity: 0.1% minimum)0.005 mg0.017 g16.67 g
NaFeEDTA(Activity: 13% minimum)6 15.0 mg50.0 g384_62 g
Zinc oxide(Activity: 80% minimum) 30.0 mg100.0 g125 g
Diluent' To complete 1000g
Notes1,Based on a dosage rate of 300 g per metric tonne (300 9/MT) dosage. Adjustment ofthe dosage rate should comply with the relevant minimum requirements indicated inTable 5, Annexure V.2.Fortfficants and diluents should pass through a 250pm sieve.3.Retinoi equivalents (RE) = 1 mcg retinol = 3.33 lU (International units) vitamin A.
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4.Use of 1% cyanocobalamin is permitted with suitable adjustment of the fortification mixformulation.NaFeEDTA shall comply with the requìrements stipulated in the latest edition of theFood Chemicals Codex.
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TABLE 3
FOR FiGATlON MIX' FOR HIGHLY FORTIFIED MAIZE MEAL ORMAIZE FLOUR
Fortificts and di!Minimumrnicronutrieaatrequiremients(per 1 kg maizemeal/flour)ilAiriimummicroriuùterequirement (perkg fortificationmix)Minimum forti;fiGantrequirement(glkgfortification mix)
Vitamin A palmiiate2(Activity: 75 000 mcg RE5600 mg1244.45 mg16.59 gThiaminmononitrate(Activity: 81% minimum) 7.0tng1.56 g1.92 gRiboflavin(Activity: assumed 100%) 4.0mg0.89 g0.89gNicotinamideiniacinamide{Activity: 99% minimum) 72.0mg16:00 g16.16 gPyridpxine HCf(Activity: 82 % miniurri)6.0mg 1.63 gFolicacid(Activity:94,5°lä minimum) 1.2mg0,27 g029gCyanocobalamin (watersoluble)(Activity: 0.1% minintum)42.4 mg2.4 g
C}-Biotin(Activity; 100°k, minimum) 0.2mg0.04 g4,04 gCalcium D panthothenate(Activity:89.3°!4 minimum) 24.0mg5.33 g5.98 gNaFeEDTA
(Activity: 13% minimum) 52.5mg11.67 g69.74 gFerrous Fumarate(Activity: 31.5%minimum)652.5mg11.67 g37.01 g
Zinc gluconate(Activity: 12.5% minimum) 33mg7.33 g58.86 gF'otassium iodide'(Activity,74.3°b0.95mg0.21 g0.28 g
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minimum)Sodium selenite(Activity: 45.6% minimum) 0,18mg0.04 g(109 g
L-LysineHCI(Activity: 80% minimum)2000,0mg444.44 g55556 g
Diluent To complete 1 000
Notes1.Based on a dosage rate of 4 500 g per metric tanne (4 500 gIMT) dosage. Adjustment
of the dosage rate should comply with the relevant minimum requirements indicated inTable 6, Annexure V.2.Retinol equivalents (RE)1 mcg retinal333 IU, (International units) vitamin A.3,Use of 10% dilution or adequate dilution with pro rata adjustment of the fortificationformulation.4.Use of 1% cyanocobalarnin is permitted with pro rata adjustment of the minimum
requirements indicate in Table 3,NaFeEDTA shall comply with the requirements stipulated in the latest edition of theFood Chemicals Codex,6,Ferrous fumarate shall comply with the requirements stipulated in the latest version ofthe Food Chemicals Codex.7.Use of 10% dilution or adequate dilution with pro rata adjustment of the minimumrequirements indicated in Table 3.
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ANNEXURE B
QUALITY CONTROL PRINCIPLES
MANUFACTURERS OF FORTIFIED WHEAT FLOUR, MAIZE MEAL AND HIFORTIFIED MAIZE MEALOR MAIZE FLOUR
Manufacturers of wheat flour and maize meat shall according to the requirements stipulatedin the Code of Practice-
(a)keep and submit monthly records of the amount of fortification mixes used everymonth and the total production of food vehicles required to be fortified per month, asindicated by the Department;
(b)ensure that fortification mixes are stored under the conditions laid down by themanufacturer;
(c)ensure that strict stock rotation procedures are adhered to in order to prevent oldstock losing potency and to comply with requirements of regulation 5(1);
(d)ensure that all critical stages of the manufacturing process are monitored to ensure
that the correct dosage levels are maintained by-(i)process control for premix addition;(ii)finished product inspection; and(iii)inspection and internal audit
(e)submit any report on fortification quality control as required by the Department.
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ANNEXURE C
QUALITY CONTROL PRINCIPLES
REGISTERED MANUFACTURERS OR SUPPLIERS OF FORTIFICATION MIXES
Registered manufacturers, importers upplieofrtification mixes shall-
(a)keep monthly records of the quantities of fortification mixes sold to wheat flour andmaize meal manufacturers as well as a list of the names and addresses of theaforesaid purchasers;
(b)submit to the Department of Health the total fortification mixes for fortifiable maizemeal, wheat flour and highly fortified maize meal or maize flour sold to millers perprovince;
(c)ensure that the quality standard for diluents and fortificants, independently or mixedwith a diluent shall be in accordance with the standards as determined in the latestedition of Food Chemicals Codex;
(d)ensure that each batch of a fortification mix for the various vehicles complies with thefortification standards described in Tables 1, Table 2 and Table 3;
(e)have one inspection audit per year at their premises, as well as the taking of samplesfor laboratory analysis by means of methods that are SANAS accredited and forvitamin A stability;
(f)have samples taken for laboratory analysis, by means of methods that are SANASaccredited from their warehouses and from the premises of manufacturers of foodvehicles
(g)bear the costsudit and analysis mentioned in paragraphs(e)and (f),
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ANURE D
APPLICATION FORM FOR REGISTRATION OF FORTIFICATION MIXES:MANUFACTURERS, IMPORTERS & SUPPLIERS
1.Company Name:2,Company address (Postal):3.Company street address:4.Company Tel No.5.Company Fax No,6.E-mail address:7Names of (Print please)
Managing DirectorQuality Assurance ManagerProduction Manager
8.Activities/facilities:
Are you: YesNoA packer?A co-packer?A manufacturer?
A distributor?an importer?
9.is the company registered for Good Manufacturing Practices in terms ofthe Medicines and Related Substances Act, 1965 (Act No 101 of 1965)?10.Has the company been inspected by the Inspectors (appointed in terms of theMedicines and Related Substances Act, 1965 (Act No 101 of 1965)Yes/No11.If yes, mention the date of the last inspection:12.Does your company have ISO certification? Yes/no(If yes, attach a copy of applicable certification)13.Does your company have HACCP accreditation? Yes/No(If yes, attach a copy of applicable certification)14.Do you have a Quality Control Laboratory? Yes/No15.Of those ingredients used in the manufacturing of fortification mixes, indicate whichingredients are:
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Self manufactured by your company in South Africa:
Imported from the mother company elsewhere in the world:
Acquired from outside the borders of South Africa:
Acquired in South Africa:
16.How long has the company been in the business of manufacturing or sellingfortification mixes?(number) years17,Source of vitamin A compound (specify the manufacturers in the case of multiplesources and attach a certificate for each manufacturer):17.1Spray-dried vitamin A powder17.2Oil-based vitamin A ,and17.3Spray-dried
18.Sources of NaFeEDTA ancl where applicable, ferrous fumarate(specify manufacturer and attach certificate/s)
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)
Vitamin A stability specification:The stability of the vitamin A compound should comply with the DOH specification, i.ea loss of not more than 15% at 40 `3C and 75 RH after 15 days
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ANNEXURE E
CERTIFICATE OF FORTIFICATION MIX COMPLIANCE(This certificate is not transferable from one batch to another)
1.Company Name:
2.Company address (Postal):
3.Company street addre
4.Company Tel No.
5,Company Fax No.
E-man addre
7.DECLARATION:It is hereby certified that (batch) fortificationmixcomplies qualitatively and quantitatively with the followingspecification:
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TABLE
TEST FORMAT FOR FORTIFICATION MIX SPECIFICATION FOR WhEAT FLOUR
FottificantsMinimumrnicronutrientrequirementadded per 1 kgfortification mixResult
Vitamin AThiaminRiboflavinNiacinamidePyridoxineFolicacidCyanocobalaminIronZincFortification mix dosagerateFortification mix particlesizeIron EDTA Respective batch certificate from manufacturerattached
Signed by:Authorised signatoryDate:SealPrinted name
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TABLE 2
TEST FORMAT FOR FORTIFICATION MIX SPECIFICATION FOR MAIZE MEAL
FortificantsMinimummicronutrientrequirementadded per 1 kgfortification mixResult
Vitamin AThiaminRiboflavinNiacinamidePyridoxineFolicacidCyanocobalaminIronZincFortification mix dosagerateIron EDTA Respective batch certificate from manufacturattached
Signed by:Authorised signatoryDate:SealPrinted nar
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TABLE 3
TEST FT FOR FORTIFICATION MIX SPECIFICATION FOR HIGHLY FORTIFIEDMAIZE MEAL OR MAIZE FLOUR
Fortificante anddiluentMinimum micronutrientrequirement added per 1 kgfortification mix Result
Vitamin AThiaminRiboflavinNiacinamide
PyridoxineFolicacidCyanocobalarninBiotinPanthothenic acidIronZincicit eSeleniumL- LysineFortification mix dosagerateRespective batch certificate from manufacturer attachedIron EDTA
Signed byAuthorised signatoryDate:SealPrinted name
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ANNEXURE F
ADDITION RATE OF FORTIFICATION MIXES
TABLE 1:
Minimum foffificant requirement (g/kg fortification mix): wheat flour
Addition rate per tonwheat flour 300 9350 g ,ii g500 gingredientgikggikgg/kgkVitamin A palmitate(Activity: 75 000 mcgRE3/g)79.3868.0459.5347.63
Thiaminmononitrate(Activity: 81% minimum) 7.988.845.994.79
Riboflavin(Activity: 100% minimum) 5.905.064.433.54
Nicotinamide/niacinarnide(Activity: 99% minimum) 79.8068.4059.8547,88
Pyridoxine NCI(Activity: 82% minimum) 10.699.168.026.41
Folicacid
(Activity: 90.5% mínimum) 5.274.513,953.16
Cyanocobaiamin (watersoluble)(Activity: 0,1% minimum)416,6714.2912.510.0
NaFeEDTA
(Activity: 13% minimum)5 384.62 329.67 288.46230.77
Zinc oxide(Activity: 80% minimum) 125,0107.1493.7575.0
DiluentTo complete1000 gTo complete1000 gTo complete1000 gTo complete1000 g
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TABLE 2
Minimum fortificant requirement kg fortification mix): Maize meal(super, special, sifted,unsifted, precooked)
Addition rate per tonize meal300 g360 g400 g600 g
Ingredient k kgikgVitamin A palmitate(Activity: 75 000 mcgRE/g)92.6779.4369.5055.60
Thiaminmononitrate(Activity: 81% minimum) 9.017.728.765.41
Riboflavin(Activity: 100% minimum) 5.634.834.233.38NicotinamicletniacinamideActivity: 99% minimum) 84.1872.1563.1350.51Folicacid
(Activity: 90.5% minimum) 7.376.315.524.42Cyanocobalamin (watersoluble)(Activity: 0.1% minimum)416,6714.2912.5010.0
NaFeEDTA(Activity: 13% minimum) 384.62329.672.46230.77Zinc oxide(Activity: 80minimum)125107,1493.7575.0DiluentTo complete1000gTo complete1000gTocomplete1000gTo complete1000g
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TAB3
Minimum fortificant requirement fortification mix): Highly a dl ormaize flour
Addition rater tonmaize meal or maizeflour4 500 g 6 030 g
Inigredient fkgglkgVitamin Aitate-{Activity: 75 000 mcg RE 16.59 14.93
ThiaminmQnonitrate(Activity_ 81% minimum) 1.92 1.73
Riboflavin(Activity: assumed 100%) 0.89 0:8
Nicotinamide/niacinamide(Activity: 99% minimum) 16.16 14.55
Pyridoxine HC(
(Activity: 82 % minimum)1 _63 1.46
Folicacid(Activity:90.5°kminimum)0.29 0.27Cyanocobalamin (watersoluble)(Activity: 0.1% mínimum)°2.4 2.16
D-Biotin(Activity: 100% minimum) 0.04 0,04
Calcium D panthothenate(Activity:89.3°fo minimum) 5.98 5.38
PlaFeEDTA(Activity: 13%minimum)89.74 80.77
Ferrous Fumarate(Activity_ 31.5%minimum)g37.01 33.31
Zinc gluconate(Activity: 12.5% minimum) 58.79 52.97
Potassium iodide7(Activity: 74.3% minimum) 0.28 0.25
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Sodium selenite(Activity: 45.6% mium)0.09 0,08
L-Lyel-ICI(Activity: 80°!a minimum) 555.56 500
Diluent To ccmplete 1 000 9 To complete 1 000 g
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ANNEXURE G
Facsimile(Monochrome copy)
Facsimile 2 (Full colour copy)
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ANNEXURE
Facsimile I (Monochrome copies)
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Facsimile 2 (Full co1ou copies)
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ANNEXURE d
HIGHLY FOR F#ED
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This gazette is also available free online at www.gpwonline.co.za34  No. 3977 6  GOVERNMENT GAZETTE, 3 MARCH 2016This gazette is also available free online at www.gpwonline.co.za STAATSKOERANT, 3 MAAR T 2016  No. 3977 6   35This gazette is also available free online at www.gpwonline.co.zaPrinted by and obtainable from the Government Printer, Bosman Street, Private Bag X85, Pretoria, 0001
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