Uganda National Bureau of Standards. Revision of the Salt Iodisation Regulations and Standards for Iodised Salt in Uganda

Transcription

1 Uganda National Bureau of Standards Revision of the Salt Iodisation Regulations and Standards for Iodised Salt in Uganda Final Report Geoffrey Onen, P.O. Box th July 2010 This Report is submitted to Uganda National Bureau of Standards being the final report of a Consultancy assignment to review the Foods and Drugs (Control of quality) (Iodated salt) Regulations, 1997 and Standards for Iodised Food Grade Salt for Uganda. The assignment was undertaken during the months of May 2010 to July 2010.

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3 LIST OF ACRONYMS A2Z - The USAID Micronutrient and Child Blindness Project IDD - Iodine Deficiency Disorders MOH - Ministry of Health TGR - Total Goitre Rate TORs -Terms of Reference UDHS - Uganda Demographic and Health Survey UFNC - Uganda Food and Nutrition Council UFNP - Uganda Food and Nutrition Policy UNBS - Uganda National Bureau of Standards UNICEF - United Nations Children s Fund WHO - World Health Organization µg - Micrograms (millionths of a gram) UIE urinary iodine excretion ii

4 Contents 1 Introduction Purpose of the assignment Terms of reference Methodology Background Universal Salt Iodization in Uganda The current Legislations on salt iodisation The Uganda Standards for Food grade salt Implementation of the Regulations and standards Monitoring of iodine intake among the population Revision of the standards for iodised salt The standards development process Setting the amount of iodine in the salt Quality standards Fortificant for iodisation of salt The draft revised standards Revision of Regulations for salt Iodisation The process of issuing Regulations Why revise the Regulations The draft revised Regulations Implementation of standards and Regulations Conclusions and recommendations Conclusions Recommendations Bibliography Annex I: Terms of Reference Ffr Facilitation to Revise the Uganda Standards (Us 203:2006) and Regulations for Salt Iodization Annex II: TC 2.5 Nutrition and Foods for Special Dietary Needs, Meeting to Review Draft Standards for Iodised Salt iii

5 Annex III: TC 2.5 Nutrition and Foods for Special Dietary Needs, Meeting to Review Draft Regulations for Iodised Salt Annex IV: Report on Workshop for Review of Iodised Salt Regulations and Standards iv

6 1 Introduction Globally Iodine Deficiency Disorders (IDD) is a major concern to governments because of its associated public health problems. Iodine is a non-metallic trace element. It is an essential micronutrient required by humans for the synthesis of two thyroid hormones, thyroxine and tri-iodothyronine. Inadequate iodine intake and absorption leads to insufficient production of these hormones, which in turn negatively affects various organ and muscle functions, particularly the heart, liver, kidneys and most devastatingly, the developing brain. Severe iodine deficiency can cause the death of a baby. In other cases it causes impaired development of the unborn baby, abortion, still births, low birth weight, cretinism (stunted physical and mental growth), learning difficulties, reduced intelligence and goitre in older children and adults. IDD is a term used to describe the various negative effects of iodine deficiency disorders on people and animals. The control of Iodine Deficiency Disorders (IDD) through the Universal Salt Iodization (USI) strategy has achieved resounding success since the early 1990s. This progress has relied on effective multi-sectoral partnerships: Governments working with the salt industry, supported by international agencies and in functioning coordination with the civic sector and expert groups. USI strategy has been implemented in Uganda since 1994 and legislation making compulsory trade of only iodised salt for human consumption was passed in To date, every year, more than 9 out of every 10 newborns in the country are protected against IDD and its negative consequences. Salt is an ideal vehicle for iodisation because all humans need salt, making it an essential food item; it is ingested in very small quantities, every day, and is inexpensive and affordable for virtually everyone. Compared to other foods, the production and distribution of salt is relatively easy to control, and there is little chance, if any, of consuming too much of it. Fortifying salt with iodine does not change its taste or colour. In order to promote the fortification of salt with iodine and the enforcement of such requirements in Uganda, the government of Uganda through the UNBS issued standards on edible salt in These standards have since been revised in 1999 and 2006 all in an effort 1

7 to streamline the control of iodised 1 salt. Complementary to the standards the government also issued Regulations requiring mandatory iodations of all salt for human and animal consumption in These Regulations define mechanisms for control of salt in the country. In 2005, a nationwide study was carried out by the Institute of Public Health (now School of Public Health) in Mulago Hospital, Uganda, with financial and technical support from UNICEF. This study which was conducted among school children was to measure progress made in the implementation of the USI strategy. Overall, at the time of the study, 87.6% of households were consuming adequately iodised salt. Since then, proportion of households consuming adequately iodised salt in Uganda has increased to 96% as indicated by the 2006 Uganda Health and Demography survey (UDHS, 2006). The 2005 study revealed that 72.9% of the population has urinary iodine excretion concentration (UIE) above the safe level of 300 µg /l with 45.6% of the population even exceeding the UIE level of 500 µg /l. This pointed to the need to revise the regulatory tools to an appropriate level of iodine content in salt and to refine the quality control system to provide optimum benefits to the population. In 2010, the UNBS with funding support from UNICEF assigned a consultant to review the current salt Standards and Regulations. This review was intended to address the prevailing challenges to the implementation of the current edible salt standard and Regulations. This report details the process and the results of the consultant work. It consists of a background, terms of reference, methodology, recommendations, and the process and implementation plan for the next steps. 2 Purpose of the assignment The purpose of this assignment was to review the current salt Standards and Regulations. 3 Terms of reference Upon assignment to undertake the study the consultant was provided with detailed Terms of Reference for this assignment. The TORs are attached as Annex I. 1 The words iodised and iodisation in this report are used to indicate the addition of iodine to food grade salt regardless of whether the compound used for adding iodine to the salt is iodide or iodate. 2

8 4 Methodology The Consultant held the first meeting in May 2010 at UNBS office in to introduce himself to the UNBS management who were the organization supervising the Consultant. This meeting also served to enable the Consultant gets a common interpretation of terms of references with the supervisor. After this meeting the consultant visited the different stakeholders to get their opinions on the current standards and Regulations for control of iodised salt in Uganda and the general control systems. During these visits, a wide variety of information and data of the respective stakeholders was collected as guided by the terms of reference. This included National Health, Food and Nutrition Policies and Programs, other relevant policies and Legislations, information on the national actors in the salt sector including mandates, functions, operational plans and systems, successes, problems and prospects, regional and international standards work, and an assessment of the level of support required in the implementation of standards and technical Regulations and conformity assessments. Information was gathered through study of available materials, direct interviews and discussions with public agencies as well as business stakeholders including civil society agencies. The Consultant then reviewed the current standards for iodised salt (US 203:2006) to incorporate proposals for change of the standard. The Consultant also reviewed the current Regulations on salt iodisation (The Food and Drugs (Control of quality) (Iodated salt), Regulations, 1997 to produce a proposed revised Regulations in line with the proposed revised standard. These documents were submitted to the Uganda National Bureau of Standards for internal discussions and comments. On June 17 th 2010 UNBS convened a meeting of the Technical Committee on Nutrition and Foods for Special Dietary Uses (UNBS TC 2-5) to discuss the draft revised standards for salt. The Consultant facilitated this meeting and took records of the comments of the Committee members. The Committee adopted the draft standard with amendments as a committee draft and recommended that the document be subjected to wider stakeholders review for further comments. A list of participants in this meeting is attached as Annex II. 3

9 On July 1 st 2010, a second Technical Committee meeting of TC 2-5 was convened to discuss proposals for the Draft Revised Regulations for iodated salt meant for human and animal consumption. Furthermore information on the different approaches and procedures were taken into account, in order to develop an acceptable national legislation, fulfilling all requirements and getting international recognition and acceptance. The list of stakeholders who were present is in Annex III. The Consultant thereafter produced the draft revised Standard for iodised salt and draft revised Regulations for iodisation of salt. These drafts were circulated to stakeholders by UNBS requesting for comments. On July 13 th 2010, UNBS convened a workshop of stakeholders to sensitize the stakeholders on the revision of the regulatory tools, enhance stakeholder networking and seek comments of the stakeholders on the draft revised documents. The Consultant facilitated this meeting and made records of the proceedings. The report of this workshop is Annex IV. The consultant then produced a final draft revised Regulations for adoption by the top management of Ministry of Health and a Revised Standard for iodised Food Grade Salt that will be presented to the National Standards Council for adoption as a National Standard. 5 Background. 5.1 Universal Salt Iodization in Uganda Uganda started to implement a policy of Universal Salt Iodization in the early 1990 s when it was launched by the Ministry of Health in a national drive to reduce IDD. By 1994 a standard for iodised edible salt was adopted and by 1997 Regulations on iodised salt came into force. The Regulations require all the salt being used at the house hold to be iodised and only iodised salt enters the country. As a consequence of this plan of action Uganda has registered great success with the Universal Salt Iodization program (USI) and has reduced Iodine Deficiency Disorders (IDD) in the last two decades. As of 2006, more than 95 % of households were reported to access adequately iodised salt protecting more than 9 out of every 10 newborns in the country against IDD and its negative consequences every year. 4

10 The nutritional requirement for iodine in humans varies with age and physiological conditions such as pregnancy when need is elevated by the presence of a growing foetus. Current guides on iodine needs indicate that the daily intake of iodine should be as follows: 90 µg for preschool children (0 to 59 months); 120 µg for schoolchildren (6 to 12 years); 150 µg for adolescents (above 12 years) and adults; and 250 µg for pregnant and lactating women. Deficiency in iodine arise when inadequate intake occurs or when need rises such as occurs during pregnancy. Measurement of the concentration of Urinary Iodine Excretion (UIE) is currently the most practical biochemical marker for iodine nutrition when carried out with appropriate technology and sampling. This approach assesses iodine nutrition only at the time of measurement and therefore is not affected by past deficiency effects. In children and non-pregnant women, median urinary iodine concentrations of between 100 µg/l and 299 µg/l define a population which has no iodine deficiency. In addition, not more than 20% of samples should be below 50 µg/l. In non-pregnant, non-lactating women, a urinary iodine concentration of 100 µg/l corresponds roughly to a daily iodine intake of about 150 µg under steady-state conditions. During pregnancy, median urinary iodine concentrations of between 150 µg/l and 249 µg/l define a population which has no iodine deficiency. UIE levels below 99 µg/l are considered as an indicator of inadequate iodine intake in normal adult populations (excluding pregnant women), values between 200 µg/l and 299 µg/l are interpreted as showing intakes above requirements and when UIE is more than 300 µg/l iodine intakes is considered as excessive 2 in such populations. In pregnant women the corresponding figures are less than 150 µg/l, indicating inadequate intake; 250 µg/l to 499 µg/l as above requirement and above 500 µg/l as excessive. When iodine intake is excessive the risk of adverse health consequences such as iodine-induced hyperthyroidism and autoimmune thyroid diseases rises. Recent studies (2005) conducted by the School of Public Health, Makerere University, in Uganda showed that although 3.9% of the population had UIE below the recommended 100 mcg/l and 1% had very low UIE excretion, below 50 µg/l, the majority of the population (72.9%) had UIE above the safe level of 300 µg/l with 45.6% of the population even 2 The term excessive is used to mean in excess of the amount required to prevent and control iodine deficiency. 5

11 exceeding the UIE level of 500 µg/l. These findings have been attributed to the iodine in salt being too high and possibly a poor monitoring system in the country. More than 90% of salt for human consumption in Uganda is imported. The remaining 10% or less of the salt could be coming from Lake Katwe where salt mining is carried out in Uganda. Salt mining from the lake is reported to be a source of livelihood to over 3,000 people in the area. This salt is however not iodised and is therefore not destined for human consumption. The control of salt iodisation therefore relied on control of imports. The control of salt iodisation is based on national standards issued by UNBS and the Regulations issued under the Food and Drugs Act. Because of the outcome of the 2005 study, there has been a call to reduce the level of iodine in the current food grade salt standard and in the Regulations. 5.2 The current Legislations on salt iodisation Salt is categorized as food. The basic Law for control of food in Uganda is the Food and Drugs Act (CAP 278). This Law prescribes basic food safety principles and requires food placed on sale be safe for human consumption and be labeled in a non deceptive manner. The Law also declares that a label or advertisement calculated to mislead as to the nutritional or dietary value of food is calculated as to mislead as to the quality of the food. The box below shows the quotation from the Law. No person shall add any substance to food, use any substance as an ingredient in preparation of food, abstract any constituent from food or subject food to any process or treatment so as in any case to render the food injurious to health, with intent that the food shall be sold for human consumption in the state a person who gives with any food sold by him or her or displays with any food or exposed by him or her for sale, a label whether attached to or printed on wrapper or container or not, which falsely describes the food; or is calculated to mislead as to its nature, substance or quality, commits an offence Quotes from the Food and Drugs Act (CAP 278) 6

12 This Law gives permission to the Minister of Health to declare Regulations for the proper implementation of the Law. In one section the law states prescribes conditions under which the Minister may issue Regulations as seen in the box below. The Minister may make Regulations for any of the following: Requiring, prohibiting or regulating the addition of any specified substance or any substance of any specified class, to food intended for human consumption or any class of such food or the use any such substance as an ingredient in preparation of such food, and generally for regulating the composition of such food; Quotes from the Food and Drugs Act (CAP 278) The current Regulations on salt iodisation (The Food and Drugs ((Control of Quality) (Iodated Salt)) Regulations, 1997) were issued by the Minister of Health in 1997, on the basis of the Food and Drugs Act (Cap 278). The government of Uganda also concluded a policy on food and Nutrition: The Food and Nutrition Policy, This policy has since lead to the drafting of a bill on food and nutrition. This bill is still in the process of promulgation into law. When promulgated this bill may provide avenues for nutrition issues, including iodine nutrition, in Uganda. The current Regulations on salt iodisation in Uganda have been implemented since 1997 making salt iodization is mandatory. These Regulations details requirements for covering all salt for human and livestock consumption that is imported, produced, or marketed in Uganda. The Regulations also call for iodations of salt using potassium iodate to levels specified in the Regulations, proper packaging and labeling procedure of iodised salt; sets appropriate conditions for storage, transport, and retail of salt; Provides for monitoring and enforcement at entry/border post, at factory/warehouses, at wholesale point, and at any point of distribution. In addition the Regulations require the salt to conform to other standards prescribed by the Uganda National Bureau of standards (UNBS). 7

13 The Regulations also give Ministry of Health responsibility of sensitization of the public and calls for the creation of a National Council to oversee and coordinate IDD control programs in Uganda. In addition the Regulations sought to establish a designated laboratory for salt analysis. The creation of the National Council for control of IDDs and the designation of laboratory had not been effected since This created a sort of non compliance situation or weak link in the implementation of the Universal Salt Iodisation program. A cross section of stakeholders in the salt industry indicated that the Regulations had not been fully implemented; was not in line with the standards and needed review to provide a better amendment mechanism in order to enhance control of iodised salt in Uganda. 5.3 The Uganda Standards for Food grade salt. The Uganda Standards Food Grade Salt was first issued by the Uganda National Bureau of Standards (UNBS) in 1994 under the UNBS act (Cap 327). This Act establishes UNBS and mandates it to formulate national standard specifications and codes of practices as may from time to time be required; to require certain products to conform to certain standards in manufacture, composition, treatment or performance; prohibit substandard goods where necessary and to enforce standards in the protection of the public against harmful ingredients, dangerous components, shoddy materials and poor performance among other functions. The standards for salt; US 203: 2006, Edible salt Specification, was first issued in 1994 and subsequently revised in 1999 and In the 1994, standard, the minimum level of iodine (as I 2 ) in salt was prescribed as 100mg/kg. There was no mention of point of control (production, entry or retail/market) or maximum level of iodine permitted in salt. The 1999, revised standard for salt iodization, prescribed the level of Iodine (as I 2 ), in salt as a minimum of 100mg/kg at point of production and application of Regulations at point of entry for imports. No maximum level of iodine in salt was set. After revision of the standards in 2006, the iodine levels were set at minimum of 40mg/kg at production and minimum of 30 at the retail market place with a maximum of 80 mg/kg in both cases. 8

14 It was observed that the standards had been progressively revised in an effort to address concerns such as points of control of the salt and the maximum levels of iodine which had evolved over time. The standards however remained non-harmonised with the Regulations which provided for various levels of iodine in salt that was tagged to certain per capita salt consumption figures and climatic conditions without identifying which of the figures were applicable to the country. 5.4 Implementation of the Regulations and standards A rigorous quality control system has been put in place by The Ministry of Health and implemented by the Uganda National Bureau of Standards (UNBS) and the Uganda Revenue Authority (URA). Iodine level in salt for human consumption is systematically checked at entry point and a certificate is delivered by UNBS if the salt found satisfactory, otherwise, the consignment is denied entry. A second level of quality control lies in URA where all salt consignments, before being cleared should have the certificate delivered by UNBS. Otherwise, the stock is ceased. Similar effective monitoring has also shown good results in other countries. In addition to these levels of control, UNBS inspectors and public health inspectors under the Ministries of health and local governments occasionally check salt in the market place for conformity to standards. A weakness in the system has been that only qualitative tests can be done in the border entry points and salt that does not indicate substantive amounts of iodine must be shipped to the laboratories in for analysis. This has sometimes created pressure for the inspectors when consignments are delayed while awaiting results from the Laboratories. In addition due to inadequate capacity in laboratories and within the inspectorate no planned monitoring of salt is undertaken. It was therefore difficult to get data to confirm the levels of iodine in the salt in the market over a period of time since 1997 and indeed to trace the impact of revision of the standards conducted since It follows therefore that the review of the systems may continue to be less informed than desirable. 9

15 The only report published in 2008 by the Ministry of health, with support from the A2Z/ The USAID Micronutrient and Child Blindness Project, when salt samples were drawn from different parts of the country in 2007 and 2008, however, indicated the level of iodine in salt was between 50 mg/kg and 60 mg/kg. This was judged, in accordance with the current standards for salt (30mg/kg to 80 mg/kg in US 203:2006) as very good in terms of conformity to standards. The study concluded that if such a situation was maintained and constantly enforced, Uganda was going to iodine deficiency under control. 5.5 Monitoring of iodine intake among the population In 1991, iodine deficiency disorders were reported as a severe public health problem in Uganda. In 1994, the Ministry of Health (MOH) developed a plan of action for the control of iodine deficiency disorders, through a strategy known as Universal Salt Iodization (USI). The USI was launched to ensure that only adequately iodised salt enters the country. After 5 years (in 1999) of USI action, MOH undertook a monitoring activity to determine goitre prevalence in the country; establish the proportion of household population consuming adequately iodised salt; and determine the levels of iodine intake using urinary iodine excretion (UIE). The 1999 study (published in 2002) showed that total goitre rate (TGR) in Uganda was at 60.2% with the number of households consuming adequately iodised salt (>15mg/kg) at 63.4%. These figures showed unacceptable prevalence of TGR and number of households consuming adequately iodised salt when compared with WHO guidelines of <5% TGR and >90% for households consuming adequately iodised salt, respectively. The study also showed 5.1% of the population showing urinary iodine levels below 50 ug/l, a medium urinary iodine level on 310 ug/l and 52.9 % of the population showing urinary iodine levels above 300 ug/l the upper limit recommended by WHO. The WHO recommends less than 20% of population with UIE below 50 ug/l and median of 300 ug/l. This study concluded that the levels of TGR were still high, the proportion of households consuming adequately iodised salt was low and yet there was a proportion of the population showing excessive UIE levels, a situation that called for redress. This study probably led to the listing 10

16 by WHO 3 of Uganda among the 29 countries worldwide where there is a risk of adverse health consequences due to excessive iodine intake. A similar study conducted by the Schoool of Public Health, Makerere Univeristy in 2005 revealed that 87.6% of households were consuming adequately iodised salt, 3.9% of the population has UIE below the recommended 100 ug/l and only 1% had very low UIE excretion, below 50 ug/l. The same study (2005) however showed that 72.9% of the population has UIE above the safe level of 300 ug/l with 45.6% of the population even exceeding the UIE level of 500 ug/l /l. It is probable that little awareness and action was generated by the 1999 study since little action was done to lower the levels of iodine in standards. The 2005 study has however been presented to stakeholders quite widely and has now initiated actions to revise the standards. UNICEF, in 2009, in a concept paper presented at the Ministry of health made the request for the revision. 6 Revision of the standards for iodised salt 6.1 The standards development process The current standard for salt in Uganda is Uganda Standard (US) 203:2006. Standards are issued by the UNBS under the UNBS Act (cap 327). The Standard on salt specifies the minimum level of iodine in salt of 30 mg/kg and a maximum of 80 mg/kg at retail level. This standard is implemented together with the Regulations on salt iodations that require iodine at level 100mg/kg, without specific provisions on the maximum limits. It has been agreed that the standard and the Regulations should be revised concurrently to provide harmony. The procedure for development of standards indicates that standards may be revised at least every 5 years with flexibility allowing a revision at any time provided there is justification to do so. Such justification is interpreted to mean changes in technology, knowledge or the needs of society. At the UNBS standards are developed through Technical committees. A Technical Committee (TC) is constituted from representatives of key stakeholders including the government, academia, research, industry (manufacturers, and traders) and consumers. The 3 Anderson, M., Takkouche, B., Egli, I., Allen, E.H., and Benoist, B, Current global iodine status and progress over the last decade towards the elimination of iodine deficiency. Bulletin of the World Health Organization, 83(7). WHO (World Health Organization), Benoist, B., Anderson, M., Egli, I., Takkouche,B and Allen, H. (Eds).Iodine status worldwide. WHO Global Database on Iodine Deficiency. WHO, Geneva. 11

17 UNBS acts as a Secretariat preparing draft documents which are then considered by the TC. Once a TC is satisfied that document is adequate to be used as a standard, the document is circulated for wider consultations to get stakeholder inputs. In order to hasten this process a stakeholder s workshop is often convened and stakeholders make comments on the spot. The comments obtained in this stage are considered by the TC before the drafts are submitted to the National Standards Council (NSC) for approval as national standards. A number of TCs handle the standards development process in various sectors. A TC on Food and agriculture (UNBS TC 2) handles all standards in the food sector. Under this TC are several subcommittees. A subcommittee on Nutrition and foods for special dietary uses handles standards on nutrition including food fortification. It was reported that the TC on Food and Agriculture Standards (UNBS TC 2) during its meeting in 2009, had agreed to revise the standard basing on the request by UNICEF. During this revision process the consultant reviewed available information and produced a draft standard that was discussed by the TC. The TC adopted a draft which was circulated to stakeholders and discussed in a stakeholders workshop. The comments of the workshop were compiled, presented and considered by the technical committee in October The TC agreed on the final draft document for approval by the National Standards Council (NSC). 6.2 Setting the amount of iodine in the salt In proposing changes to the standard the consultant considered the following: 1. The UDHS 2006 reported 96% of the households consuming adequately iodised salt implying that about 4% of the population does not access adequately iodised salt. Moreover 11.2 % of households surveyed had no salt during the survey. This suggests that probably not all households have access to salt at all times. 2. Data provided by A2Z Project indicated that average salt consumption in Uganda was at 10g per person per day. Salt consumption like any other parameter of a population would be normally distributed. This implies that some portions of the population may 12

18 be consuming high amounts of salt and still some others consume little or no salt at all. The iodine intake therefore would be varied due to such factors. 3. Losses of iodine in salt during its shelf life are estimated at about 15-20%. No specific data was available from local studies to show the extent of loss of iodine under local conditions of handling, storage, distribution and food preparation. Besides the quality of the salt in the market place was generally observed to be high. The national standards for salt were said to be aligned with the international standards of Codex Alimentarius Commission at least in principle. 4. Uganda imports more than 90 % of the salt consumed in the country. The remaining 10 % of the salt is locally produced. However the salt produced locally is not iodised due to technical problems with quality of the salt and low awareness on the value of iodisation of the salt among the salt producers. Due to the fact that most salt is imported the harmonization of the standards between Uganda and trade partners is very essential in aiding compliance with Regulations. Besides to aid compliance to Regulations, the market supply and demand dynamics must be able to provide iodised salt in the market without incentives for non compliance. 5. The nutrient reference values for iodine recommended in international standards are 150ug per day. There is no data to show what this figure means to an average Ugandan. Uganda National Bureau of Standards has adopted the 150µg per day as a nutrient reference value for iodine for the Uganda a population for nutritional labeling purposes. The estimation of the level of iodine to be added to salt is undertaken as illustrated in the Box below. This calculation is based on the assumption that the per capita consumption for salt is 10 g. However an average consumption of salt of 10 g implies that a proportion of the populations consumes less than 10 grams and the salt iodisation program should consider such a population as a target since this portion of the population are more likely to be deficient than those that consume high salt levels. In Table 1 is shown the variation of salt consumption in a population with an average consumption of 10g per person per day. 13

19 Assuming the iodine requirement per person per day =150 µg Assuming the average consumption of salt of 10 µg per person per day Assuming the loss in iodine during distribution and food preparation of 15% To receive 150 µg in a day would require 150 µg in 10 g of salt This implies 10 g contain 150 µg 1 g would contain 150µg/10 µ Therefore 1 kg (1000g) would contain =15000µg of iodine per kg of salt or 15mg/kg Factoring in losses of 15% during handling implies that the level of addition should be = = 18.75mg/kg. At the level of consumption of 5g the value would =37.5mg/kg Table 1: Variation of per individual salt consumption in a population in Uganda a Proportional to Adult Equivalent Units COUNTRY RURAL URBAN Percentiles Percentiles Percentiles UBOS HIES b Conclusion: Minimum intake of salt = 1.9 g/day Maximum intake = 19.1 g/day for the country. a. Adopted from ECSA M&E2. Estimating the daily intake of salt (g/day) using HIES data (in Uganda). East Central and Southern Africa (ECSA) health community, Monitoring and evaluation technical working group meeting,, July b. UBOS HIES= Uganda Bureau Of Statistics House Hold Income and Expenditure Survey For purposes of Regulations it is vital, too, to factor in variations of iodine in salt that arise due to inherent variability of the manufacturing process. Additionally there will be analytical variability due to difference in accuracy during the determination of iodine in the laboratory. Variability up to 20% has been reported. Such variability in analysis and other variability are otherwise considered as tolerances that may be allowed in Regulations. Computation of levels of iodine intake for the various population portions depending on levels of salt intake was done using the Food Fortification Formulator 4. The formulator takes into consideration several factors including inherent amounts of nutrients in the food vehicles, losses attributable to handling and preparation of foods, the coefficients of variation 4 A Food Fortification Formulator is a compilation of worksheets that provide dynamic ability to consider food safety, nutritional goals with other factors in designing fortified foods. This formulator is quite popular in the East, Central and Southern Africa (ECSA) region. 14

20 during manufacturing and the per capita consumption of the food vehicle by the target population. The formulator also considers safety of those consumers who may be taking higher levels of the fortified products while taking care that those at the bottom of the consumption distribution who are most in need get substantial amounts of nutrients in fortified foods. Available literature indicates that consumption of iodine up to 1mg a day will not lead to toxicity concerns in normal populations. On the other hand international standards of the Codex Alimentarius Commission recommend at least 15% of the nutrient reference values for a nutrient claim to be made in foods. It follows that for iodized salt it would be vital to deliver at least 22.5 µg of iodine in an amount an average person may consume in a day. This recommendation however is based on the premise that people would get the nutrient form other food sources to fulfill their daily need. For iodine, due to apparent absence in ordinary diets, salt iodisation is expected to deliver nearly 100 % of the need. Table 2 shows various levels of iodine intake for various salt intake levels. Basing on this table the target salt iodisation was estimated at 45 mg/kg.. Table 2. Potential intakes of iodine at different fortification levels c Food Salt intake (g/day) Iodine intake (µg/day) from iodate using salt as the vehicle Iodine intake (µg/day) per adult equivalent GOAL: 156 to 654 µg/day Factory (mg/kg) Home (mg/kg) Users Mean SD Percentiles Most: % ,138 Conclusion: Use 45 mg/kg and monitor excretion of urinary iodine. When iodine excretion results are known, then decrease or increase level of iodine in salt as needed. Here is important to remember that the HIES estimates only salt intake from cooking and table salt. c Adopted from Adopted from ECSA M&E workshop document: Assessing Potential intakes of iodine at different fortification levels. East, Central and Southern Africa (ECSA) health community, Monitoring and evaluation technical working group meeting,, July Therefore the range for the standards was suggested and adopted to be between 25mg/kg and 50 mg/kg. A draft standard with this level of iodine was presented to the Stakeholders workshop for discussion. The report of the workshop will be used to enable the Committee finalize the draft standards 15

21 6.3 Quality standards The current standard for salt was found to have a number of provisions that had never been implemented. For example there was no information on trade in coarse salt as defined in the standards; edible salt that is predominantly made of sodium chloride, and is a crystalline solid of white, pale pink, or light grey colour; from which food grade common salt, free flowing table salt and diary salt are processed. It was therefore chosen to have the Uganda standards harmonized with Codex Standards (Codex Standard For Food Grade Salt, CX STAN ), as much as possible. 6.4 Fortificant for iodisation of salt It was noted that the current standards for salt and the Regulations on salt iodisation limited the fortificant of choice to only potassium iodate. It was however observed by some stakeholders that some salt iodised with iodide compound was entering the country and inspectors sometimes had challenges dealing with such product especially if the salt contains prescribed amounts of iodine and the importers demands justification for any denial of entry of the salt. The Codex standards for food grade salt indicate that both iodate and iodide may be used for salt iodisation. In the interest of harmonization it was suggested that the fortificants for salt should be either iodide or iodate. 6.5 The draft revised standards The final draft revised standard for iodised salt was developed, discussed by the committee. This draft was circulated to stakeholders and discussed during the stakeholders workshop. The comments of the workshop and other comments from stakeholders were compiled and presented together with the draft to the TC for consideration. The TC then confirmed the final draft standards which is now due for approval by the National Standards Council and is attached as Annex V. The draft standard is designed to be simple to aid in the implementation of salt iodisation program. This draft standard is intended to cover only salt for human consumption and does not therefore make provisions of the kind that would apply to salt for animal consumption. It is understood that salt for animal consumption may have different levels on iodine and other 16

22 constituents such as bone meal, lime may be added depending on the animal species in question. In future it may be necessary for UNBS to set a standard for salt for animal consumption as this would aid the production of such salt from the locally available salt sources such as Lake Katwe. Such efforts would be complementary to the salt iodisation program as it would help provide market for salt that may not be used for human consumption. 7 Revision of Regulations for salt Iodisation 7.1 The process of issuing Regulations The Food and Drugs Act, the basic law on food control provides that the Minister of Health may issue Regulations requiring the addition of any substance to food for the purpose achievement of the objectives of the Law. The current (2010) Regulations were issued in In order to keep up to date with technological and knowledge development Regulations may be amended or revised. If the foreseen changes are substantive and could lead to a very pronounced change in the Regulations, revising the Regulations may be the better option. Regulations are usually drafted by the technical personnel who are involved in the day to day activities covered by a given law. The Regulations have to be approved through the Ministry responsible for legislation. This ensures that consistency with the laws of the land is maintained. Drafts thus cleared are then signed by the responsible Minister and then published in the national Gazette. 7.2 Why revise the Regulations The current (2010) Regulations on salt iodisation (The Food and drugs Act (Control of quality) (iodated salt)) Regulations, 1997) made provisions some of which have not been implemented at all. For example, the Regulations called for the creation of a National Council for Control of Iodine Deficiency Disorders (NCCIDD). This provision was of an institutional nature and that may explain why they were not implemented. This is probably because Regulations may not create institutions of national nature without the involvement of the Parliament. The Regulations also provided for levels of iodine to be added to the salt for human consumption. Unfortunately there were more than 8 different levels provided depending on 17

23 the per capita salt intake and the climate of the area of concern. This provision was therefore not clear to the inspectors who enforce the Regulations. Additionally, in 2005, the government issued another set of Regulations on food fortification which broadly define principles for the addition of nutrients to food and establishes the food fortification logo that is intended for the creation of awareness among the general public on micronutrient deficiencies and food fortification as a strategy for control. It was therefore vital that the current Regulations were revised to harmonize with the standards and provide a mechanism for improved quality assurance and control of iodised salt and better monitoring of salt iodisation program in the fight against IDDs. 7.3 The draft revised Regulations The draft revised Regulations for salt iodisation in Uganda is attached to this report as an insert (Annex VI) because it is an independent document which has to be published. The consultant reviewed the current regulations, proposed areas for amendment and presented the proposals to a Technical committee. The committee reviewed the proposals in line with current industry practices, experiences and challenges and adopted amendment as necessary. The committee draft was then circulated to stakeholders and resented at the stakeholders workshop. The workshop reviewed the proposed changes, made comments and discussed and accepted changes to the draft. The comments were then compiled and presented to the technical committee for final consideration. The final draft revised regulations was then adopted by the technical committee for submission to the Ministries of Health and Justice and Constitutional Affairs for final approved. During the review of the Regulations, consideration was given to salt iodine intake concerns; institutional mandates; the current technology; implementation modalities including conformity assessment and enforcement; synchronizing the regulation for iodised salt with other fortified products together with their promotion. The draft revised Regulations have attempted to capture the whole regulatory system as it may be in Uganda. The draft revised Regulations is comprised of areas for action which will provide direction to achieve the vision, goal and targets of Universal Salt Iodisation in Uganda. These areas are (a) Requiring all salt for human and animal consumption to be iodized. This is intended to avoid circumstances where salt may be put on the market as if it were for animal consumption and the salt finds its way to the tables. Moreover although there is no other 18

24 regulation or standard for salt for animal consumption, animals also need iodine for normal development and well being; (b) Requiring all salt produced, imported or marketed in Uganda to be iodised using either potassium or sodium iodide or iodate to conform to set national standards for food grade salt. This provision avoids the prescription of iodisation levels in the Regulations and opts to leave this detail to the standard which is seen as a more flexible document amenable to review as and when new information is availed; (c) Defining packaging and labeling requirement in line with USI and market requirements. This provision included permitting the use of the food fortification logo on salt for the purposes of public awareness promotion; (d) Establishing a minimum shelf life of salt at entry point to avoid salt that has already stayed in the market place to be brought into the country and risk loss of iodine during its distribution; (e) Requiring quality assurance procedures to be adhered to in line with National Health Policies to protect public health and safety; (f) Establishing enforcement activities to ensure compliance with the Regulations and providing penalties for violation of the Regulations; (g) The Regulations also establish responsibilities of sensitization of the general public and monitoring of the benefits and objectives of the Regulations as functions of the ministry of health; and (h) The Regulations establish cases where salt may not be iodised and exempts such cases from the requirement to comply with the Regulations. The current draft Regulations leave out the establishment of a council for the control of IDDs as an independent body. Instead it is foreseen that the National Food and Nutrition Council currently (2010) under formulation will be able to handle issues of nutrition including iodine nutrition and will be able to coordinate efforts towards to total and eternal elimination of IDDS in Uganda. 19

25 The current review of the Regulations for salt provides for an effective administrative mechanism, a result oriented quality assurance system that brings together a public private sector partnership. The proposed revised draft is phased in, to ensure that the appropriate level of iodine in the form of iodate/iodide is added, labeling and packaging procedures are carried out correctly, warehouse storage procedures are followed, and monitoring and enforcement activities are understood and acceptable to all involved. Along with this revised Regulations and standards is an action plan which when implemented will effectively contribute towards o The total eradication of IDD in Uganda. o Improved level of protection of the public health and safety of the people of Uganda. Overall the Regulations and the standards are closely related and provide an opportunity to look at the regulatory framework in a holistic manner. 8 Implementation of standards and Regulations The objectives of USI cannot succeed unless all salt for human consumption is being adequately iodised. Various stakeholders need to fulfil their mandate for mutual benefits. This calls for monitoring 5 of implementation. Monitoring may take place in two forms: 1) monitoring the salt for adequate iodisation and 2) monitoring the population for adequate iodine intake. The most important indicator to monitor is salt. The most important place to monitor salt is at the site of production and importation. If all salt leaving production facilities and imported salt is properly iodised, packaged, and labelled, populations consuming this salt are likely to have their iodine requirements met. In Uganda due to largely relying on imported salt as a source of salt for human consumption, monitoring at border pints has worked very well in the past. 5 The two levels of monitoring 1) monitoring the salt and 2) monitoring the population are also referred to as regulatory monitoring and household monitoring. Regulatory monitoring covers the more or less quality assurance activities that are intended to ensure that the salt is adequately iodised. The household monitoring on the other hand seek to evaluate whether the program actually works. 20

26 The next level of monitoring is to answer the question: Does the population actually access and consume adequately iodised salt and does the whole system translate into the health of the population. At this stage the most important indicator to monitor is the population itself. This stage of monitoring is usually conducted at household level where information on both the likely iodine intake and iodine status, is obtained making it easier to distinguish between difficulties with iodised salt quality, and iodised salt use. When adequately iodised salt is used, this should be reflected in adequate iodine status in the population sampled. The recommended implementation mechanisms for salt iodisation Regulations and standards in Uganda is summarised in Table 3. 9 Conclusions and recommendations 9.1 Conclusions A lot of information is available on the role of iodine in human health and development. Efforts to enable Uganda benefit from available technology of salt iodisation have been largely successful leading more than 96 % of households consuming adequately iodised salt. Due to apparently high per capita consumption of salt in the country, portions of the population appear to be exposed to excessive iodine intake which may be detrimental to health. Revision the current regulatory tools, awareness strategies and partnership arrangement is essential for better performance including maintenance of achievements attained, avoidance of negative effects of excessive intakes and total elimination of IDDs in Uganda. The regulatory management in Uganda is amenable to updating and continuous improvement. Knowledge transfer and sharing is vital for the achievement of effective updating of both regulatory tools and management mechanisms. 21

27 Table 3: Implementation of regulations and standards for salt iodisation Level of monitoring Location Objective Activities Indicators Responsible agency Collaborating agencies Planning - Factories Regulatory Entry points To ensure monitoring activity is undertaken in all essential control points To ensure that all salt leaving production facilities properly iodized, packaged, and labelled To ensure that all salt imported salt is properly iodized, packaged, and labelled Design, develop and publish monitoring manuals Monitoring manuals UNBS MoLG, MOH, UNICEF Design publish monitoring plan to include factory, entry point and retail, annually Monitoring plan UNBS MoLG, MOH, UNICEF Visit production sites according to plan Inspection reports UNBS URA Draw samples of iodised salt according to plan Sampling reports UNBS URA Test samples quantitatively for iodine Test report Inspect each consignment of salt for Certificate Of Conformity, proper packaging and labelling Draw samples of salt for on-the-spot tests for each brand in each consignment Report UNBS URA, MOH, UNICEF Sampling/test reports UNBS Draw samples for quantitative analysis in laboratory Test reports UNBS URA URA Test samples quantitatively for iodine Test reports UNBS UIRI, GAL Household Reporting Retail Households/ schools Households /schools Households/ Schools UNBS office To verify the availability of iodized salt to the consumer To establish proportion of households consuming iodised salt at different concentrations of iodine To establish likely iodine intake and iodine status of the population To verify that USI is working and that IDD is not re-emerging To ensure monitoring feeds back and is used in continued improvement Draw samples of iodised salt for on-the spot test and Sampling/test UNBS, GAL, MOH, MoLG laboratory analysis reports UNICEF Draw samples for quantitative analysis in laboratory Sampling reports MoLG MOH, MoLG Test samples quantitatively for iodine Test reports UNBS MOH, MoLG Draw samples of salt from households/schools and test for iodine Draw samples of salt at households/schools and analyse of iodine content Draw samples of urine at households/schools and analyse UIE Survey reports Reports Survey reports (UIE levels: median) Assess thyroid functions of the population Survey reports MOH UNICEF MOH MOH MOH MoLG, MoES, UBOS, UNICEF UBOS, MAK, MoLG, MoES UBOS, MAK, MoLG, MoES Report writing Reports UNBS MOH,MoLG,UNICEF 22