Fortified Wheat Flour - Specification (Rwanda Standard 767)

ICS 67.060 Reference number RS EAS 767: 2019 © RSB 2019 RWANDA STANDARD RS EAS 767 (IDT) Second edition Adopted by RSB 2019-09-13 Fortified wheat flour — Specification LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 ICS 67.060 © EAC 2019 Second Edition 2019 EAST AFRICAN STANDARD Fortified wheat flour — Specification EAST AFRICAN COMMUNITY LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 ii © EAC 2019 – All rights reserved Copyright notice This EAC document is copyright-protected by the EAC. While the reproduction of this document by participants in the EAC standards development process is permitted without prior permission from EAC, neither this document nor any extract from it may be reproduced, stored or transmitted in any form for any other purpose without prior written permission from EAC. Requests for permission to reproduce this document for the purpose of selling it should be addressed as shown below or to EAC’s member body in the country of the requester: © East African Community 2019 — All rights reserved East African Community P.O. Box 1096, Arusha Tanzania Tel: + 255 27 2162100 Fax: + 255 27 2162190 E-mail: eac@eachq.org Web: www.eac-quality.net Reproduction for sales purposes may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 © EAC 2019 – All rights reserved iii Contents Page Foreword ............................................................................................................................................................ iv Introduction ......................................................................................................................................................... v 1 Scope ...................................................................................................................................................... 1 2 Normative references ............................................................................................................................ 1 3 Terms and definitions ........................................................................................................................... 2 4 Requirements ......................................................................................................................................... 4 4.1 Raw materials ........................................................................................................................................ 4 4.2 General requirements ........................................................................................................................... 4 4.3 Specific requirements ........................................................................................................................... 4 4.4 Self-raising flour .................................................................................................................................... 5 5 Fortification requirements .................................................................................................................... 5 5.1 Levels of micronutrients ....................................................................................................................... 5 5.2 Fortificants and fortification premixes ................................................................................................ 5 6 Food additives ....................................................................................................................................... 6 7 Hygiene ................................................................................................................................................... 6 8 Contaminants ......................................................................................................................................... 6 8.1 Heavy metals .......................................................................................................................................... 6 8.2 Pesticide residues ................................................................................................................................. 6 8.3 Mycotoxins ............................................................................................................................................. 6 9 Weights and measures ......................................................................................................................... 7 10 Packaging ............................................................................................................................................... 7 11 Labelling ................................................................................................................................................. 7 11.1 General labelling .................................................................................................................................... 7 11.2 Nutrition labelling .................................................................................................................................. 8 11.3 Nutrition and health claims .................................................................................................................. 8 12 Sampling ................................................................................................................................................ 8 Annex A (informative) Fortification premix .................................................................................................... 9 A.1 Fortificants ............................................................................................................................................. 9 A.2 Fortification premix ............................................................................................................................... 9 A.3 Stability of fortificants and fortification premixes ........................................................................... 11 Bibliography ...................................................................................................................................................... 13 LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 iv © EAC 2019 – All rights reserved Foreword Development of the East African Standards has been necessitated by the need for harmonizing requirements governing quality of products and services in the East African Community. It is envisaged that through harmonized standardization, trade barriers that are encountered when goods and services are exchanged within the Community will be removed. The Community has established an East African Standards Committee (EASC) mandated to develop and issue East African Standards (EAS). The Committee is composed of representatives of the National Standards Bodies in Partner States, together with the representatives from the public and private sector organizations in the community. East African Standards are developed through Technical Committees that are representative of key stakeholders including government, academia, consumer groups, private sector and other interested parties. Draft East African Standards are circulated to stakeholders through the National Standards Bodies in the Partner States. The comments received are discussed and incorporated before finalization of standards, in accordance with the Principles and procedures for development of East African Standards. East African Standards are subject to review, to keep pace with technological advances. Users of the East African Standards are therefore expected to ensure that they always have the latest versions of the standards they are implementing. FDEAS 767 was prepared by Technical Committee EASC/TC 018, Nutrition and Foods for Special Dietary Uses. Attention is drawn to the possibility that some of the elements of this document may be subject of patent rights. EAC shall not be held responsible for identifying any or all such patent rights. This second edition cancels and replaces the first 2012 edition (EAS 767: 2012), which has been technically revised. LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 © EAC 2019 – All rights reserved v Introduction The Health Ministers of the East, Central and Southern Africa Health Community (ECSA-HC) passed a resolution in 2002 directing the Secretariat to work with the countries to fortify commonly consumed foods in the region after recognizing that there is high level of malnutrition in the region. ECSA-HC is an intergovernmental organization that fosters cooperation in health among countries in the East, Central and Southern African Region. ECSA-HC members include Kenya, Uganda, Tanzania, Malawi, Zambia, Zimbabwe, Lesotho, Swaziland, Mauritius and Seychelles. Following initial promotion efforts, the countries identified staple foods suitable for fortification as oil, sugar, maize meal/ flour and wheat flour. These foods can be used as vehicles to deliver essential micronutrients to the populations. Based on scientific evidence and working with countries using country data, the Secretariat developed implementation focused guidelines on fortification of these foods to help countries start up programmes and scale up the existing programmes. These guidelines included fortification levels for addition of micronutrients at the factory, and levels for monitoring at commercial level. Based on the guidelines and other available information, most of the countries in the East African Region and in the larger Africa have initiated national programmes on oil fortification with vitamin A; and wheat and maize meal/flour fortification with iron, zinc, folic acid, niacin, vitamin B-1, B-2, B-12, B-6 and vitamin A. Sugar fortification with vitamin A has also been considered as a way of supplementing other sources of the vitamin in order to prevent and reduce problems associated with the deficiency of this vitamin. Salt fortification with iodine continues to be implemented in all the countries. With the increased trade of food commodities including these fortified foods within the region, it has become imperative to develop regional standards that over and above the other standards, stipulate minimum and maximum levels of the added nutrients, provide clauses on how to pack the fortified product and the use of health and nutrition claims. The guidelines developed through ECSA have now been incorporated into food standards to provide for specific fortified products. It is envisaged that, the implementation of these standard within the region will help countries adopt food fortification as a strategy to prevent, alleviate or eliminate micronutrient deficiency in the region. Standards will not only promote the health of the population but will also ensure safety of food products and enhance fair trade. LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAST AFRICAN STANDARD EAS 767: 2019 © EAC 2019 – All rights reserved 1 Fortified wheat flour — Specification 1 Scope This East African Standard specifies the requirements, sampling and test methods for fortified wheat flour prepared from common wheat (Triticum aestivum L.), club wheat (T. compactum Host.) or a mixture thereof intended for human consumption. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. AOAC 2001.13, Determination of Vitamin A (Retinol) in food — Liquid Chromatography AOAC 2004.05, Total folates in cereal and cereal foods — Microbiological Assay-Trienzyme Procedure AOAC 2011.14, Calcium, Copper, Iron, Magnesium, Manganese, Potassium, Phosphorus, Sodium and Zinc in fortified food products. Microwave Digestion and Inductively Coupled Plasma-Optical Emission Spectromatry AOAC 932.03, Determination of Carbon dioxide (total) in self-rising flour AOAC 944.02, Iron in flour. Spectrophotometric method AOAC 952.13, Arsenic in food — Silver diethyldithiocarbamate AOAC 953.17, Thiamine (vitamin B1) in grain products. Fluorometric (rapid) method AOAC 961.15, Vitamin B6 (pyridoxine,pyridoxal,pyridoxamine) in food extracts. Microbiological method AOAC 970.65, Riboflavin (Vitamin B2) in foods and vitamin preparations AOAC 975.41, Niacin and niacinamide in cereal products. Automated method CODEX STAN 192, General standard for food additives EAS 1, Wheat flour — Specification EAS 38, Labelling of pre-packaged foods — Specification EAS 39, Code of practice for hygiene in the food and drink manufacturing industry EAS 44, Milled maize products — Specification EAS 51, Wheat grains — Specification EAS 803, Nutrition labelling — Requirements LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 2 © EAC 2019 – All rights reserved EAS 804, Claims on food — General requirements EAS 805, Use of nutrition and health claims — Requirements EAS 900, Cereals and Pulses - Sampling EAS 901, Cereals and Pulses – Test Methods ISO 16649-2, Microbiology of food and animal feeding stuffs -- Horizontal method for the enumeration of beta- glucuronidase-positive Escherichia coli -- Part 2: Colony-count technique at 44 degrees C using 5-bromo-4- chloro-3-indolyl beta-D-glucuronide ISO 20634, Infant formula and adult nutritionals — Determination of vitamin B12 by reversed phase high performance liquid chromatography (RP-HPLC) ISO 21527-2, Microbiology of food and animal feedstuffs — Horizontal method for the enumeration of yeasts and moulds — Part 2: Colony count technique in products with water activity less than or equal to 0.95 ISO 2171, Cereals, pulses and by-products — Determination of ash yield by incineration ISO 4833-1, Microbiology of the food chain -- Horizontal method for the enumeration of microorganisms -- Part 1: Colony count at 30 degrees C by the pour plate technique ISO 5498, Agricultural food products — Determination crude fibre content — General method ISO 6561-1, Fruits, vegetables and derived products — Determination of cadmium content — Part 1 — Method using graphite furnace atomic absorption spectrometry ISO 6561-2, Fruits, vegetables and derived products -- Determination of cadmium content -- Part 2: Method using flame atomic absorption spectrometry ISO 6579-1, Microbiology of the food chain -- Horizontal method for the detection, enumeration and serotyping of Salmonella -- Part 1: Detection of Salmonella spp. ISO 6633, Fruits, vegetables and derived products — Determination of lead content — Flameless atomic absorption spectrometric method ISO 6888-1, Microbiology of food and animal feeding stuffs — Horizontal method for the enumeration of coagulase-positive staphylococci (Staphylococcus aureus and other species) — Part 1: Technique using Baird-Parker agar medium 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 diluent suitable, inert, edible food-grade carrier for micronutrients 3.2 fortification premix blend of fortificants and diluents formulated to provide specified and determinable amounts of micronutrients 3.3 fortified wheat flour wheat flour to which essential micronutrients have been added 3.4 fortificant compound which contains essential micronutrient intended to be added to a food LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 © EAC 2019 – All rights reserved 3 3.5 food fortification practice of deliberately increasing the content of an essential micronutrient, i.e. vitamins and minerals (including trace elements) in a food, so as to improve the nutritional quality of the food supply and provide a public health benefit with minimal risk to health 3.6 wheat flour product prepared from common wheat grain, Triticum aestivum L. or club wheat, Triticum compactum Host, or mixtures thereof by grinding or milling process 3.7 white wheat flour wheat flour obtained by milling wheat grains at extraction rates that leaves negligible amounts of bran 3.8 baker’s flour white wheat flour made from semi hard/hard wheat which has a medium to high protein content intended for bread making 3.9 home baking/all-purpose flour white wheat flour obtained by milling either soft wheat grains or blends of hard and soft wheat grains used for making wide range of baked products 3.10 biscuit flour white wheat flour obtained by milling soft wheat or a blend of hard and soft wheat with a high percentage of soft wheat for biscuit manufacture 3.11 cracker flour white wheat flour obtained by milling medium protein wheat with no improvers 3.12 self-raising flour white wheat flour obtained by milling soft or a blend of soft and hard wheat to which raising agents are added 3.13 standard flour wheat flour obtained by milling wheat grains at a higher extraction than home baking flour 3.14 wholemeal flour wheat flour obtained by milling the entire wheat grain to fine particle size without any separation 3.15 atta flour wheat flour of high extraction rate or white wheat flour to which pollard and or bran are blended 3.16 food grade packaging material material which will safeguard the hygienic, nutritional, technological, and organoleptic qualities of the product 3.17 foreign matter organic or inorganic material other than wheat flour LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 4 © EAC 2019 – All rights reserved 3.18 patent flour White wheat flour obtained by milling wheat grains at a lower extraction rate 4 Requirements 4.1 Raw materials Fortified wheat flour shall be prepared from wheat flour complying with EAS 1 or wheat grains complying with EAS 51. 4.2 General requirements 4.2.1 Edible salt, if used, shall comply with EAS 35. 4.2.2 Fortified wheat flour shall: a) have the characteristic colour of the wheat flour; b) be free from any objectionable flavours and odours; c) be free from insects, worms, fungal infestation, rodent contaminations and foreign matter; and d) not contain flour from other cereals. However, the addition of malted barley flour not exceeding 1 % is permissible in the case of baker’s flour. 4.3 Specific requirements Fortified wheat flour shall comply with the requirements given in Table 1 when tested in accordance with the test methods specified therein. Table 1 — Specific requirements for fortified wheat flour S/N Characteristic Requirements Test method Paten t wheat flour Baker’s flour Home baking flour Biscuit flour Cracker flour Self- raising flour Standa rd flour Atta flour Whole meal flour i. Moisture content, max.%, m/m 14 14 14 14 14 14 14 14 14 EAS 901, Clause 5 ii. Crude fibre content, max.%, m/m 1.0 1.0 1.0 1.0 1.0 1.0 1.5 2.0 2.0 ISO 5498 iii. Total ash content, max.%, m/m 0.7 0.8 0.8 0.8 0.8 3.0 1.10 2.0 2.0 ISO 2171 iv. Residue on sieving through 180-micron sieve, max % 0.5 0.8 0.8 0.8 0.8 0.80 30.0 55.0 30.0 EAS 901, Clause 4 v. Crude protein content, min. % m/m 8.0 9.0 8.0 8.0 8.0 8.0 9.0 8.0 8.0 EAS 901, Clause 6 LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 © EAC 2019 – All rights reserved 5 4.4 Self-raising flour In addition to the specific requirements in Table 1, self-raising fortified wheat flour shall contain the following: a) sodium bicarbonate in sufficient amounts to provide not less than 0.4 % of available carbon dioxide when tested in accordance with AOAC 932.03; and b) acid ingredients singly or in combination including sodium acid pyrophosphate, mono acid calcium phosphate and sodium aluminium phosphate. 5 Fortification requirements 5.1 Levels of micronutrients The fortified wheat flour shall comply with the levels of micronutrients provided in Table 2 when tested in accordance with test methods specified therein. Table 2 — Requirements for levels of micronutrients in fortified wheat flour Nutrient Fortificant Limits mg/kg Test method Min. Max. Vitamin Aa Vitamin A (Retinyl) palmitate, spray- dried or equivalent, 75 000 μg RE/gb (7.5 % retinol), min. 0.5 1.4 AOAC 2001.13 Vitamin B1 a Thiamin Mononitrate, 81 %, min. 4.6 NAc AOAC 953.17 Vitamin B2 a Riboflavin, 100 %, min. 3.3 NA AOAC 970.65 Niacina Niacinamide, 99 %, min. 30 NA AOAC 975.41 Vitamin B6 a Pyridoxine hydrochloride, 82 %, min. 3 NA AOAC 961.15 Folate Folic acid, 90.5 %, min. 1.1 3.2 AOAC 2004.05 Vitamin B12 Vitamin B12 (Water soluble), 0.1 %,min. 0.01 NA ISO 20634 Zinc Zinc oxide, 80 %, min. 40 80 AOAC 2011.14 Total iron Total iron 20 NA AOAC 944.02 a The addition of these micronutrients is optional in Tanzania. b 1μg RE = 3.33 IU, RE = Retinol equivalent. c NA-Not Applicable. The maximum limits for these nutrients are not necessary because the upper tolerance limits of these nutrients are very high. NOTE 1 Any other fortificants listed by either British Pharmacopoeia (BP); Food Chemical Codex (FCC); Merck Index (MI); United States National Formulary (NF); European Pharmacopoeia (Ph Eur); United States Pharmacopoeia (USP); or FAO WHO Codex Alimentarius Commission may be used. NOTE 2 Only NaFeEDTA, 12.5 % Fe, min or Ferrous fumarate, 32 %, min shall be used as a source of iron so as to provide iron at 20-40 mg/kg and 30-50 mg/kg respectively for wheat flour fortification. 5.2 Fortificants and fortification premixes The fortificants and fortification premixes may be formulated in accordance with Annex A. LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 6 © EAC 2019 – All rights reserved 6 Food additives 6.1 Fortified wheat flour may contain food additives in accordance with CODEX STAN 192. 6.2 Azordicarbonamide (ADA) and potassium bromate shall not be used. 7 Hygiene 7.1 Fortified wheat flour shall be produced, prepared and handled in accordance with EAS 39. 7.2 The product shall comply with microbiological limits given in Table 3 when tested in accordance with the test methods specified therein. Table 3 — Microbiological limits for fortified wheat flour S/N Micro-organism Maximum limit Test method i. Total aerobic count, cfu/g 105 ISO 4833-1 ii. Escherichia coli per g <1x102 ISO 16649-2 iii. Salmonella spp in 25 g Absent ISO 6579-1 iv. Yeast and moulds, cfu/g 104 ISO 21527-2 v. Staphylococcus aureus, cfu/ g 102 ISO 6888-1 8 Contaminants 8.1 Heavy metals Fortified wheat flour shall comply with maximum limits for heavy metals as given in Table 4 when tested in accordance with the test methods specified therein. Table 4 — Heavy metals limits in fortified wheat flour S/N Heavy metal Limit mg/kg Test method i. Arsenic (As) 0.1 AOAC 952.13 ii. Lead (Pb) 0.2 ISO 6633 iii. Cadmium (Cd) 0.1 ISO 6561-1 ISO 6561-2 8.2 Pesticide residues Fortified wheat flour shall comply with the maximum pesticide residue limits established by the Codex Alimentarius Commission for this commodity. NOTE Where the use of certain pesticides is prohibited by some Partner States, then it should be notified to all Partner States accordingly. 8.3 Mycotoxins Fortified wheat flour shall comply with the mycotoxin limits as given in Table 5 when tested in accordance with the test methods specified therein. LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 © EAC 2019 – All rights reserved 7 Table 5 — Mycotoxins limits in fortified wheat flour S/N Mycotoxin Maximum limit µg/kg Test method EAS 901 i. Total aflatoxins 10 Clause 9 Clause 10 ii. Aflatoxin B1 5 iii. Fumonisins 2 000 Clause 11 Clause 12 9 Weights and measures Fortified wheat flour shall be packaged in accordance with the weights and measures regulations of the destination country. NOTE EAC Partner States are signatory to the International Labour Organizations (ILO) Convention for maximum package weight of 50 kg where human loading and offloading is involved. 10 Packaging 10.1 Fortified wheat flour shall be packaged in food grade packaging materials. 10.2 When the product is packaged in sacks, they shall be clean, sturdy and strongly sewn or sealed. 11 Labelling 11.1 General labelling In addition to the requirements in EAS 38, each package shall be legibly and indelibly marked with the following: a) product name as “Fortified wheat flour”; b) type of wheat flour; c) name, address and physical location of the manufacturer/ packer/importer; d) lot or batch number in code or in clear format; e) brand name or registered trade mark, if any; f) net weight, in metric units; g) the declaration “Human Food’’; h) storage instruction as “Store in a cool dry place away from any contaminants’’; i) date of manufacture; j) best before date; k) instructions on disposal of used package; and l) country of origin. LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 8 © EAC 2019 – All rights reserved NOTE Each product unit may also be marked with the national food fortification Logo, where the industry qualifies to use the mark. 11.2 Nutrition labelling The names and the amount of the nutrients added in the fortified wheat flour shall be declared on the label in accordance with EAS 803. 11.3 Nutrition and health claims Where permitted by national legislation, fortified wheat flour may have claims on the importance of the added nutrients in nutrition and health. Such claims when declared shall be in compliance with EAS 804 and EAS 805. 12 Sampling Sampling shall be done in accordance with EAS 900. LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 © EAC 2019 – All rights reserved 9 Annex A (informative) Fortification premix A.1 Fortificants Fortificants for use shall be stable compounds complying with the specification of any of the following documents; a) British Pharmacopoeia (BP); b) Food Chemical Codex (FCC); c) Merck Index (MI); d) United States National Formulary (NF); e) European Pharmacopoeia (Ph Eur); f) United States Pharmacopoeia (USP); and g) FAO/WHO Codex Alimentarius Commission (CAC) A.2 Fortification premix The fortificants may be mixed with diluents or carrier as appropriate to form a fortification premix. Diluents or carriers shall comply with USP, BP, Ph. Eur, NF, MI, FAO/WHO CAC or FCC. The fortification premix shall be made in such a way that at a given rate of addition to the product, the product shall comply with the requirements in Table 2. The fortification premix may be formulated to comply with the provisions given in Table A.1 or Table A.2 when Fumarate or NaFeEDTA is used respectively. Where the fortification premix is made in accordance with Table A.1 and Table A.2, the addition rate shall be 500 g of fortification premix per metric tonne of wheat flour. The fortification premix shall be labelled with the addition rate (that is the amount of fortification premix to be added to the wheat flour) in grams of fortification premix per metric tonne of wheat flour and dilution factor. NOTE This fortification premix formulation Table A.1 and A.2 is designed with minimum nutrient composition and does not take into consideration factory overages in the preparations of the fortification premix. LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 10 © EAC 2019 – All rights reserved Table A.1 — Formulation of fortification mix for addition of vitamins and minerals to wheat flour if using ferrous fumarate as source of iron Nutrient Fortificant Amount of micronutrient to be added to wheat flour, mg/kg Amount of fortificant to be added to wheat flour, mg/kg Amount of fortificant in fortification premix, g/kg Amount of nutrient in fortification premix, g/kg Vitamin A VitaminA (Retinyl) palmitate , spray dried or equivalent, 75 000 μg RE/ga (7.5 % retinol) retinol, min. 1 13.3 26.6 2 Vitamin B1 Thiamin Mononitrate, activity level, 81%, min. 9 11.1 22.2 18 Vitamin B2 Riboflavin, activity level, 100 %, min. 6 6.0 12.0 12 Vitamin B3 (Niacin) Niacinamide, activity level, 99 %, min. 50 50.5 101.0 100 Vitamin B6 Pyridoxine, activity level, 82 %, min. 6 7.3 14.6 12 Vitamin B9 (Folate) Folic acid, activity level, 90.5 %, min. 2 2.2 4.4 4 Vitamin B12 Vitamin B12 (Water soluble form), activity level, 0.1 %), min. 0.02 20.0 40.0 0.04 Iron Ferrous fumarate, activity level, 32 %, Fe, min. 40 125.0 250.0 80 Zinc Zinc oxide, activity level, 80 %, min. 30 37.5 75 60 Filling material (at least 25 %) 227.1 454.2 ‒ TOTAL 500 1 000.0 ‒ LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 © EAC 2019 – All rights reserved 11 Table A.2 — Formulation of fortification mix for addition of vitamins and minerals to wheat flour if using NaFeEDTA as source of Iron Nutrient Fortificant Amount of micronutrient to be added to wheat flour, mg/kg Amount of fortificant to be added to wheat flour, mg/kg Amount of fortificant in fortification premix, g/kg Amount of nutrient in fortification premix, g/kg Vitamin A Vitamin A (Retinyl) palmitate , spraydriedor equivalent, 75 000 μg RE/ga (7.5 % retinol) retinol, min. 1 13.3 26.6 2 Vitamin B1 Thiamin Mononitrate, activity level, 81 %, min. 9 11.1 22.2 18 Vitamin B2 Riboflavin, activity level,100 %, min. 6 6.0 12.0 12 Vitamin B3 (Niacin) Niacinamide, activity level, 99 %, min. 50 50.5 101.0 100 Vitamin B6 Pyridoxine hydrochloride, activity level, 82 %, min. 6 7.3 14.6 12 Vitamin B9 (Folate) Folic acid, activity level, 90.5 %, min. 2 2.2 4.4 4 Vitamin B12 Vitamin B12, (Water soluble form), activity level, 0.1 %, min. 0.02 20.0 40.0 0.04 Iron NaFeEDTA, activity level, 12.5 % Fe, min. 30 240 480 60 Zinc Zinc oxide, activity level, 80 %, min. 30 37.5 75 60 Diluent (Filling material, at least 25 %) 112.1 224.2 - TOTAL 500 1 000.0 - A.3 Stability of fortificants and fortification premixes The supplier of the fortification premix shall provide the stability data for the fortificants and fortification premixes. LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 12 © EAC 2019 – All rights reserved The fortificants and fortification premixes shall have storage stability such that no more than 20 % of their original activity will be lost when stored for 21 days at 45 °C in a well closed container at a level of 2.5 g/kg in wheat flour having the moisture content in the range of 13.5 % - 14 % for testing stability. LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 © EAC 2019 – All rights reserved 13 Bibliography [1] EAS 767: 2012, Fortified wheat flour — Specification [2] CODEX STANDARD 152, Codex standard for wheat flour [3] ECSA-HC, Guidelines of fortification levels for staples LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767: 2019 © EAC 2019 – All rights reserved LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED RS EAS 767: 2019 (IDT) Price based on 12 pages ©RSB 2019 - All rights reserved LI C EN C ED B Y R SB T O G AI N H EA LT H O R D ER N U M BE R 6 40 90 40 5D O W N O AD ED 2 01 9- 10 -1 8 SI N G LE U SE R L IC EN C ED C O PY IN G A N D N ET W O R KI N G P R O H IB IT ED EAS 767 2019 Front cover pge EAS 767- - Fortified wheat flour-- Specification EAS 767 2019 Back cover pge