information booklet · 2020. 2. 1. · mandating wheat #our forti!cation with folic acid. wheat and...
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Information Booklet
CHEMICAL NAME SODIUM IRON (III) EDTA (ethylenediaminetetraacetate)/ Ferric Sodium EDTA CHEMICAL FORMULA EDTA FeNa . 3H2O MOLECULAR WEIGHT 421.1 CAS Number 15708-‐41-‐5 (anhydrous) 18154-‐32-‐0 (trihydrate) SpecificaQons Appearance yellow or yellowish brown crystalline powder Odour Odourless Iron content 19.5-‐20.5 Free iron 0.05 Max. Sulphates 0.06% Max. pH of a 1% w/v aqueous soluJon 4.5-‐5.5 Loss on drying 12.5-‐13.5 % Heavy metals as Pb 20 mg/Kg Max. Free disodium EDTA 1% Max. IdenJficaJon pass FERRISTAT TM is approved for food forJficaJon. Manufacture is made in strict accordance with HACCP and FS22000. FERRISTAT TM is a stable, free-‐flowing, yellow-‐brown powder, soluble in water and inherently biodegradable. Packing: For informaJon on packing possibiliJes, please contact us or your nearest sales
ND Pharma & Biotech representaJve Storage: Store in original packaging at a dry place. Opened bags and containers must be closed properly. Shelf life in opJmal condiJons is 36 months or 3-‐years equivalent.
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PURPOSE
This statement is based on scientific reviews prepared for a Flour Fortification Initiative (FFI) technical workshop held in Stone Mountain, GA, USA in 2008 where various organizations actively engaged in the prevention and control of vitamin and mineral deficiencies and various other relevant stakeholders met and discussed specific practical recommendations to guide flour fortification efforts being implemented in various countries by the public, private and civic sector. This joint statement reflects the position of the World Health Organiza-tion (WHO), Food and Agriculture Organization of the United Nations (FAO), The United Nations Children’s Fund (UNICEF), Global Alliance for Improved Nutrition (GAIN), The Micronutrient Initiative (MI) and FFI. It is intended for a wide audi-ence including food industry, scientists and governments involved in the design and implementation of flour fortification programs as public health interven-tions.
WHO and FAO published in 2006 the Guidelines on Food Fortification with Mi-cronutrients (WHO/FAO, 2006). These general guidelines, written from a nutri-tion and public health perspective are a resource for governments and agencies implementing or considering food fortification and a source of information for scientists, technologists and the food industry. Some basic principles for effec-tive fortification programs along with fortificants’ physical characteristics, se-lection and use with specific food vehicles are described. Fortification of widely distributed and consumed foods has the potential to improve the nutritional status of a large proportion of the population, and neither requires changes in dietary patterns nor individual decision for compliance. Technological issues to food fortification need to be fully resolved especially with regards to appro-priate levels of nutrients, stability of fortificant, nutrient interactions, physical properties and acceptability by consumers (WHO/FAO, 2006). Worldwide, more than 600 million metric tons of wheat and maize flours are milled annually by commercial roller mills and consumed as noodles, breads, pasta, and other flour products by people in many countries. Fortification of industrially processed wheat and maize flour, when appropriately implemented, is an effective, sim-ple, and inexpensive strategy for supplying vitamins and minerals to the diets of large segments of the world’s population. It is estimated that the proportion of industrial-scale wheat flour being fortified is 97% in the Americas, 31% in Africa, 44% in Eastern Mediterranean , 21% in South-East Asia , 6% in Europe, and 4% in the Western Pacific regions in 2007 (FFI, 2008).
Nearly 100 leading nutrition, pharmaceutical and cereal scientists and mill-ing experts from the public and private sectors from around the world met on March 30 to April 3, 2008 in Stone Mountain, GA, USA to provide advice for countries considering national wheat and/or maize flour fortification. This Second Technical Workshop on Wheat Flour Fortification: Practical Recommenda-tions for National Application was a follow up to a FFI, the US Centers for Disease Control and Prevention (CDC) and the Mexican Institute of Public Health, first technical workshop entitled “Wheat Flour Fortification: Current Knowledge and Practical Applications,” held in Cuernavaca, Mexico in December 2004 (FFI, 2004). The purpose of this second workshop was to provide guidance on na-tional fortification of wheat and maize flours, milled in industrial roller mills (i.e. >20 metric tons/day milling capacity), with iron, zinc, folic acid, vitamin B12 and vitamin A and to develop guidelines on formulations of premix based on common ranges of flour consumption. A secondary aim was to agree on the best practices guidelines for premix manufactures and millers. Expert work groups prepared technical documents reviewing published efficacy and effec-tiveness studies as well as the form and levels of fortificants currently being added to flour in different countries. The full reviews will be published in a sup-plement of Food and Nutrition Bulletin in 2009 and the summary recommenda-tions of this meeting can be found in http://www.sph.emory.edu/wheatflour/atlanta08/ (FFI, 2008).
Wheat and maize flour fortification is a preventive food-based approach to improve micronutrient status of populations over time that can be integrated with other interventions in the efforts to reduce vitamin and mineral deficien-cies when identified as public health problems. However, fortification of other appropriate food vehicles with the same and/or other nutrients should also be considered when feasible. Wheat and maize flour fortification should be con-sidered when industrially produced flour is regularly consumed by large popu-lation groups in a country. Wheat and maize flour fortification programmes could be expected to be most effective in achieving a public health impact if mandated at the national level and can help achieve international public health goals. Decisions about which nutrients to add and the appropriate amounts to add to fortify flour should be based on a series of factors including the nutri-tional needs and deficiencies of the population; the usual consumption profile of “fortifiable” flour (i.e. the total estimated amount of flour milled by
THE FFI SECOND TECHNICAL WORKSHOP ON WHEAT FLOUR FORTIFICATION
RECOMMENDATIONS FOR WHEAT AND MAIZE FLOUR FORTIFICATION
BACKGROUND
Recommendations on Wheat and Maize Flour FortificationMeeting Report: Interim Consensus Statement
WHO/NMH/NHD/MNM/09.1
industrial roller mills, produced domestically or imported, which could in prin-ciple be fortified); sensory and physical effects of the fortificant nutrients on flour and flour products; fortification of other food vehicles; population con-sumption of vitamin and mineral supplements; and costs. Flour fortification programs should include appropriate Quality Assurance and Quality Control (QA/QC) programs at mills as well as regulatory and public health monitoring of the nutrient content of fortified foods and assessment of the nutritional/health impacts of the fortification strategies. Though the wheat and maize flours can be fortified with several micronutrients, the technical workshop focused on iron, folic acid, vitamin B12, vitamin A and zinc, which are five micronutrients recognized to be of public health significance in developing countries.
IRON1.
The suggested levels for fortification of wheat flour with iron were reviewed by experts from published efficacy and effectiveness studies with various iron-fortified foods (Hurrell R et al, 2009). The authors estimated the daily amounts of selected iron compounds, including NaFeEDTA, ferrous sulphate, ferrous fu-marate and electrolytic iron that have been shown to improve iron status in populations. The selection of the type and quantity of vitamins and minerals to add to flour, either as a voluntary standard or a mandatory requirement, lies with national decision makers in each country and therefore the choice of com-pounds as well as quantities should be viewed in the context of each country’s situation. Based on available data from the Food Balance Sheets of FAO and World Bank-supported Household Income and Expenditure Surveys (HIES), it was proposed that four wheat flour average consumption ranges be considered in designing flour fortification programs: >300 g/day, 150-300 g/day, 75-150 g/day and <75 g/day.
FOLIC ACID2.
Well conducted studies from the United States (Williams LJ et al, 2002), Canada (De Wals P et al, 2007), and Chile (Hertrampf E & Cortes F, 2004) have docu-mented decreases of 26%, 42%, and 40%, respectively, in the rate of neural tube defects (NTD) affected births after implementation of national regulations mandating wheat flour fortification with folic acid. Wheat and maize flour for-tification with folic acid increases the intake of folate by women and can reduce the risk of neural tube and other birth defects.
VITAMIN B3. 12
An unpublished pilot study testing the feasibility of adding B-complex vitamins and iron to flour in Israel showed that vitamin B12 added to flour was stable during baking, did not affect the quality of the bread, and increased plasma B12 concentrations slightly within six months (Allen L et al, 2008). However, evi-dence is still lacking about the population impact of fortification of wheat flour with vitamin B12 to improve vitamin B12 status. Nevertheless, fortifying flours with vitamin B12 could be a feasible approach to improve vitamin B12 intake and the status of populations as there are no known adverse consequences of vita-min B12 fortification, and there are no known adverse effects of high intakes of the vitamin.
VITAMIN A4.
Wheat and maize flour can technically be fortified with vitamin A as vitamin A is stable in flour without producing organoleptic changes. As is the case for some other vitamins, high humidity and high temperatures can adversely affect vitamin A content during the preparation of wheat and maize flour products. Experience with vitamin A fortification of wheat and maize flour in developing
Nutrient Flour Extraction Rate Compound Level of nutrient to be addedin parts per million (ppm) by estimated
average per capita wheat flour availability (g/day)1
<752
g/day75-149 g/day
150-300 g/day
>300g/day
Iron Low NaFeEDTA 40 40 20 15
Ferrous Sulfate 60 60 30 20
Ferrous Fumarate 60 60 30 20
Electrolytic Iron NR3 NR3 60 40
High NaFeEDTA 40 40 20 15
Folic Acid Low or High Folic Acid 5.0 2.6 1.3 1.0
Vitamin B12 Low or High Cyanocobalamin 0.04 0.02 0.01 0.008
Vitamin A Low or High Vitamin A Palmitate 5.9 3 1.5 1
Zinc4 Low Zinc Oxide 95 55 40 30
High Zinc Oxide 100 100 80 70
Table 1. Average levels of nutrients to consider adding to fortified wheat flour based on extraction, fortificant compound, and estimated per capita flour availability
1. These estimated levels consider only wheat flour as main fortification vehicle in a public health program. If other mass-fortification programs with other food vehicles are implemented effectively, these suggested fortification levels may need to be adjusted downwards as needed.
2. Estimated per capita consumption of <75 g/day does not allow for addition of sufficient level of fortificant to cover micronutrients needs for women of childbearing age. Fortification of additional food vehicles and other interventions should be considered.
3. NR = Not Recommended because very high levels of electrolytic iron needed could negatively affect sensory properties of fortified flour. 4. These amounts of zinc fortification assume 5 mg zinc intake and no additional phytate intake from other dietary sources.
Allen L et al., eds. Guidelines on food fortification with micronutrients. Geneva, World Health Organization and Food and Agricultural Organization of the Unit-ed Nations, 2006.
Flour Fortification Initiative country database [online database], Flour Fortifica-tion Initiative. (http://www.sph.emory.edu/wheatflour/COUNTRYDATA/Mas-ter_Database.xls, accessed 21 August 2008).
Report of the Workshop of Wheat Flour Fortification. Cuernavaca, Mexico, Flour Fortification Initiative, 2004. (http://www.sph.emory.edu/wheatflour/CKPAFF/index.htm, accessed 21 August 2008).
Second Technical Workshop on Wheat Flour Fortification: Practical Recommenda-tions for National Application: Summary Report, Stone Mountain, GA, 30 March to 3 April 2008 . The Flour Fortification Initiative. (http://www.sph.emory.edu/wheatflour/atlanta08/ , accessed 11 December 2008).
Hurrell R, Ranum P, de Pee S, Biebinger R, Hulthen L, Johnson Q. Lynch S. Re-vised recommendations for the iron fortification of wheat flour and an evalu-ation of the expected impact of current national wheat flour fortification pro-grams. Food and Nutrition Bulletin, 2009, (Supplement). For submission.
Williams LJ et al. Prevalence of spina bifida and anencephaly during the transi-tion to mandatory folic acid fortification in the United States. Teratology, 2002, 66:33-39.
De Wals P et al. Reduction in neural-tube defects after folic acid fortification in Canada. New England Journal of Medicine, 2007, 357:135-142.
Hertrampf E, Cortes F. Folic acid fortification of wheat flour: Chile. Nutrition Review, 2004, 62:S44-S48.
Allen L and Vitamin B12 Working Group. Vitamin B12 fortification. Background Paper for the workshop, Stone Mountain, GA, 30 March to 3 April 2008. The Flour Fortification Initiative, 2008 (http://www.sph.emory.edu/wheatflour/atlan-ta08/papers.html, accessed 11 December 2008).
West KP Jr., Klemm RDW, Dary O, Palmer AC, Johnson Q, Randall P, Ranum P, Northrop-Clewes C. Vitamin A Fortification of Wheat Flour—Considerations and Current Recommendations. Food and Nutrition Bulletin, 2009, (Supple-ment). For submission.
Brown KH, Hambidge KM, Ranum P, Tyler V. and the Zinc Fortification Working Group. Zinc fortification of cereal flours: current recommendations and re-search needs. Food and Nutrition Bulletin, 2009, (Supplement). For submission.
countries is increasing. Although vitamin A is most often used in the fortifica-tion of oils and fats, currently 11 countries are fortifying or propose to fortify wheat and/or maize flour with this vitamin. Two published efficacy trials have reported the impact of vitamin A fortified wheat flour on vitamin A nutritional status but there are no published studies that have evaluated the effectiveness of this intervention on a national scale (West KP et al, 2009). Wheat and, more broadly, other cereal grain flour (e.g. maize) can be considered as a vehicle for delivery of vitamin A to populations at risk of vitamin A deficiency.
ZINC5.
Unpublished results from a trial of wheat flour fortification in China suggests that zinc fortified flour could improve zinc status in women of childbearing age (Brown K et al, 2009). Fortification of other foods with zinc has shown that zinc intake and absorption increase when some zinc fortified foods are consumed but the impact as a public health intervention remains unknown. More research on efficacy and effectiveness of large scale zinc fortification pro-grams is needed. The levels of nutrients to consider adding to fortified wheat flour based on extraction, fortificant compound, and estimated per capita flour availability are presented in Table 1. These levels and compounds could theo-retically improve the nutritional status of the populations consuming the forti-fied wheat flour regularly in different preparations.
This statement was prepared by the core group from WHO’s Department of Nutrition for Health and Development in close collaboration with FAO, the nu-trition section of UNICEF, GAIN, MI and FFI. The core group members were: Dr Francesco Branca (WHO), Dr Juan Pablo Pena-Rosas (WHO), Mr Brian Thomp-son (FAO), Mr Arnold Timmer, (UNICEF), Dr Regina Moench-Pfanner (GAIN), Dr Annie Wesley (MI) and Dr Glen Maberly (FFI). The core group evaluated the commissioned scientific reviews prepared by international nutrition, pharma-ceutical and cereal scientists and milling experts from the public and private sector working in the area of micronutrients, milling and food fortification, as well as the summary of discussions and conclusions from the consultation. This position statement is based on these documents and was initiated at WHO headquarters and further discussed and reviewed by members of the core group who provided technical and editorial advice. This statement contains all the consensus recommendations of the core group.
All members of the core group were asked to submit and sign Declaration of Interest statements which are on file. There were no known conflicts of interest disclosed among the core group members developing this statement.
It is anticipated that the recommendations in this statement will remain valid until December 2010. The Department of Nutrition for Health and Develop-ment at WHO headquarters in Geneva will be responsible for initiating a review following formal WHO Handbook for Guideline Development procedures at that time.
WHO wishes to thank the Government of Luxembourg for their financial support.
PLANS FOR UPDATE
CONFLICTS OF INTEREST
REFERENCES
SUMMARY OF STATEMENT DEVELOPMENT
Department.of Nutrition for Health and Development (NHD) World Health Organization
20, Avenue Appia, 1211 Geneva, SwitzerlandEmail: [email protected]
WHO home page: http://www.who.int
© World Health Organization 2009
FOR FURTHER INFORMATION PLEASE CONTACT
Suggested citationWHO, FAO, UNICEF, GAIN, MI, & FFI. Recommendations on wheat and maize flour fortification. Meeting Report: Interim Consensus Statement. Geneva, World Health Organization, 2009 (http://www.who.int/nutrition/publications/micro-nutrients/wheat_maize_fort.pdf, accessed [date]).
ACKNOWLEDGEMENT
1. Introduction
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) metin Geneva from 19 to 28 June 2007. The meeting was opened by SusanneWeber-Mosdorf, Assistant Director General, World Health Organization(WHO), on behalf of the Directors General of WHO and the Food andAgriculture Organization of the United Nations (FAO). Mrs Weber-Mosdorfacknowledged the important role the work of the Committee plays in theestablishment of international food safety standards and its contribution tosustainable development. She informed the Committee of the six-pointagenda that the new Director General of WHO, Dr Margaret Chan, has pro-posed for the organization. This agenda also refers to using evidence to definestrategies and measure results, and in this context the work of the Committeeis an important contribution to the goals of WHO. Mrs Weber-Mosdorfinformed the Committee that the 50th World Health Assembly approved anincreased budget for the areas of food safety and nutrition and for publichealth and the environment, which illustrated the importance the MemberStates give to these work areas. She emphasized that FAO and WHO considerthe provision of scientific advice in food safety an important and core activity.
1.1 Declarations of interests
The Secretariat informed the Committee that all experts participating in thesixty-eighth meeting of JECFA had completed declaration-of-interest formsand that no conflicts had been identified. The following declared interestsand potential conflicts were discussed by the Committee. Professor AndrewRenwick consulted for the International Sweeteners Association and hencedid not participate in the discussions on steviol glycosides. Professor GaryWilliams declared an interest in steviol glycosides and did not participate inthe discussions. The employer of Dr Ian Munro receives part of its revenuesfrom consulting on the safety assessment of food additives. The company,but not Dr Munro himself, prepared submissions regarding the assessmentsof sodium iron ethylenediaminetetraacetic acid (EDTA) and of acidifiedsodium chlorite (ASC).
1
In a 13-week study of toxicity in rats, no significant treatment-related effectswere seen when the LEC was administered by oral gavage at doses up toand including 575 mg TOS/kg bw per day. Therefore, 575 mg TOS/kg bwper day, the highest dose tested, was taken to be the NOEL. The LEC wasnot mutagenic in an assay for mutagenicity in bacteria in vitro and was notclastogenic in an assay for chromosomal aberrations in mammalian cellsin vitro.
Assessment of dietary exposure
Based on a maximum mean daily consumption of 44 g of cheese (GEMS/Food Consumption Cluster Diet E) by a 60-kg adult and on the assumptionsthat the enzyme is used at the maximum recommended use level of 350lecitase units/l milk and that all TOS originating from the enzyme preparationremain in the cheese, the dietary exposure would be 0.03 mg TOS/kg bwper day.
Evaluation
Comparing the conservative exposure estimate with the NOEL from the13-week study of oral toxicity, the margin of safety is >19 000. The Com-mittee allocated an ADI “not specified” for phospholipase A1 from thisrecombinant strain of A. oryzae, used in the applications specified and inaccordance with good manufacturing practice.
An addendum to the toxicological monograph was prepared. The existingspecifications were maintained.
3.1.8 Sodium iron(III) ethylenediaminetetraacetic acid (sodium iron EDTA)
Explanation
At the request of CCFAC at its thirty-eighth session (7), the Committee re-evaluated the safety of sodium iron(III) ethylenediaminetetraacetic acidtrihydrate (in short, sodium iron EDTA) as to its use for iron fortification.The Committee had previously evaluated sodium iron EDTA at its forty-firstand fifty-third meetings for its specific application in supervised food forti-fication programmes in populations in which iron deficiency anaemia isendemic (Annex 1, references 107 and 143). It was concluded that sodiumiron EDTA could be considered safe for use in such programmes, providingdaily intakes of iron and EDTA of approximately 0.2 and 1 mg/kg bw, re-spectively. This opinion has been perceived as being restrictive to the use ofsodium iron EDTA as a source of iron for food fortification (i.e. preventingit from being used at levels higher than 0.2 mg iron/kg bw per day andother than “under supervision only”). The Committee at its present meetingwas therefore asked to re-evaluate the safety of sodium iron EDTA for ironfortification.
48
Toxicological data
In addition to the studies already evaluated by the Committee at its earliermeetings, several new studies on the biochemical and toxicological aspectsand on the efficacy of sodium iron EDTA were submitted.
The new data provided on the biochemical aspects following administrationof sodium iron EDTA corroborate the findings from earlier studies, i.e. that
the iron in sodium iron EDTA dissociates from the chelate and is releasedinto the common non-haem iron pool before absorption;
only a very small fraction of the sodium iron EDTA complex (less than1–2%) is absorbed intact and is rapidly and completely excreted via thekidneys in the urine;
iron from sodium iron EDTA is generally more efficiently absorbed thaniron from alternative sources such as iron(II) sulfate, with less influence ofinhibitory factors present in the diet (e.g. phytic acid, polyphenols);
the same enhancing effect on iron absorption can be achieved by addingdisodium EDTA to other soluble iron fortificants, such as iron(II) sulfate.
Moreover, it was demonstrated that the human body maintains iron levelsthrough down-regulating systems, which control the amount of iron absorbedand protect against the possibility of iron overload: more iron is absorbedwhen the body is in a state of iron deficiency (with an inverse relation betweenabsorption and concentration of serum ferritin) and less when the body ironstores are replete. Besides, a 3-fold increase in the level of iron fortificationresulted in a decreased percentage of iron absorption from sodium iron EDTAin healthy adults. Also, in iron-replete subjects, non-haem iron absorptionwas reduced to a larger extent than the absorption of haem iron, whereasabsorption of iron during states of iron depletion was comparable for the twodifferent forms of iron. This tight regulation of non-haem iron absorption isof importance, given that iron from sodium iron EDTA will join the non-haem iron pool before absorption. These findings support the conclusion thatdietary iron fortification with sodium iron EDTA does not increase the riskfor iron accumulation beyond normal physiological requirements in iron-replete individuals. Studies have also provided additional evidence thatdietary intake of sodium iron EDTA has no negative influence on the ab-sorption of other minerals, such as zinc.
From the new toxicological studies provided, it can be concluded that sodiumiron EDTA is of low acute oral toxicity and that it does not induce genemutations in bacteria and mammalian cells in vitro, unless tested at high,cytotoxic concentrations.
49
The results of new intervention studies in populations with a high prevalenceof anaemia and iron deficiency in Viet Nam, China and Kenya demonstratedthe efficacy of sodium iron EDTA-fortified condiments (soy sauce and fishsauce) and sodium iron EDTA-fortified whole maize flour in reducing irondeficiency and/or iron deficiency anaemia and the prevalence of anaemia.
Evaluation
The Committee considered the new data submitted to be in support of theearlier conclusions by the Committee at its fifty-third meeting that once thenutritional requirement for iron is satisfied, administration of iron in the formof sodium iron EDTA will not result in greater uptake of iron than from otheriron fortificants (such as iron(II) sulfate), as a result of down-regulating sys-tems in the body. The Committee also noted that the new data submittedprovide additional evidence that dietary intake of sodium iron EDTA has noadverse effects on the absorption of other minerals, such as zinc.
The Committee concluded that sodium iron EDTA is suitable for use as asource of iron for food fortification to fulfil the nutritional iron requirements,provided that the total intake of iron from all food sources including con-taminants does not exceed the provisional monthly tolerable daily intake(PMTDI) of 0.8 mg/kg bw (Annex 1, reference 62). Additionally, the totalintake of EDTA should not exceed acceptable levels, also taking into accountthe intake of EDTA from the food additive use of other EDTA compounds.An ADI of 0–2.5 mg/kg bw was previously established for the calcium di-sodium and disodium salts of EDTA, equivalent to up to 1.9 mg EDTA/kg bw(Annex 1, reference 32). A preliminary exposure assessment based on sug-gested levels of fortification for sodium iron EDTA indicates that the intakeof EDTA in infants and children up to the age of 13 already is at or exceedsthe upper limit of the ADI for EDTA.
As previously noted for ferrous glycinate (Annex 1, reference 166), products,including sodium iron EDTA, that are intended to provide a source of addi-tional iron should not be consumed by individuals with any type of ironstorage disease, except under medical supervision.
An addendum to the toxicological monograph was prepared.
3.1.9 Steviol glycosides
Explanation
Steviol glycosides are natural constituents of the plant Stevia rebaudianaBertoni. Stevioside and rebaudioside A are the component glycosides ofprincipal interest for their sweetening properties.
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