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Getting started on food fortification
Educational advocacy, policy, and legislation
Monitoring and evaluation
Dr. Penelope Nestel, of Opportunities for Micronutrient Intervention (OMNI) in the United States, summarized the barriers to the process of developing a food-fortification programme. Foremost among these is the issue of cost, which is often assumed to be high. However, it is estimated that the annual cost per person covered is less than US$0.30 for vitamin A-fortified sugar, between US$0.10 and US$0.84 for iron-fortified sugar and salt, and US$0.04 for iodized salt. The cost is often less than 2% of the retail cost of the product. Other barriers include poor motivation and commitment of both government and industry, concerns about the complexity of the technology, identifying a suitable vehicle, the legislation or regulations required, a quality assurance system, and sustainability. In starting a fortification programme, Dr. Nestel emphasized the need for developing a political will. This requires the provision of adequate information on the nutritional problem being addressed and an understanding of all the elements of a fortification programme.
Dr. Muhilal, Director of the Nutrition Research and Development Centre in Bogor, Indonesia, to illustrate the conduct of clinical and field trials to determine the effectiveness of food fortification, described his centre’s experience with the fortification of monosodium glutamate (MSG) with vitamin A. After identifying vitamin A deficiency as a problem that could be solved by food fortification, a suitable vehicle, MSG, was identified on the basis of a national survey. After acceptance of the technology of fortification by industry, a clinical and field trial was conducted to determine whether the addition of vitamin A to MSG could reduce the level of xerophthalmia and raise serum vitamin A significantly. Sample size was estimated on the basis of the prevalence of xerophthalmia in the area covered. Data were collected at baseline and 6 and 11 months after the fortified MSG was marketed. Dr. Muhilal also described his centre’s experience with the fortification of instant noodles with vitamin A and iron. The indicators used to evaluate success were the increase in serum vitamin A and haemoglobin among children under five and pregnant women. Consumption of the fortified instant noodles was supervised by field workers three times a week for three months. Finally, Dr. Muhilal emphasized the important role of industry in getting fortification started. Although the development of technology starts at the research centre, that technology will eventually be transferred to industry. Therefore, advocacy to industrial managers is very important.
Dr. Kenny C. K. Koh, Area Technical Manager of Roche Singapore, discussed the importance of a quality assurance programme in food fortification. Food technologists and nutritionists need to know the extent to which the food processes and distribution systems can affect the retention of the added micronutrients and how they may minimize losses. They must not only know the technology of combining ingredients to produce attractive, safe, and nutritious foods, but also give serious consideration to labelling and cost implications. Dr. Koh emphasized the importance of an effective monitoring and surveillance system in the field together with an efficient quality control system at the manufacturing level. Inspection procedures should be risk-based, and quality assurance procedures should be based on Hazard Analysis and Critical Control Points. Finally, to ensure safe and acceptable food fortification, national guidelines must be developed following international guidelines such as the Codex Alimentarius.
Dr. Demetria C. Bongga, Nutrition Program Officer of UNICEF Philippines, discussed the data that are required before starting a fortification programme. These include the prevalence of micronutrient deficiency, which members of the population are affected, the causes of the deficiency, the recommended dietary allowance (RDA) of the nutrient, consumption data for potential vehicles, the availability of the micronutrient from the typical diet, the status of potential vehicles, the processing industry chain, the technology of fortification, and the existing guidelines for fortification, if available. After government and the private food sector have been convinced of the significant contribution that fortified foods can make in reducing micronutrient deficiency, a number of pilot production activities are needed. The food industry should be provided with assistance in the development or transfer of available fortification technology in the form of incentives such as procurement of equipment, training of plant personnel, and setting up of quality control systems. Research is important to determine the potency and stability of the fortificant, changes in physical and organoleptic qualities of the fortified product, and bio-availability of the fortificant. Standards of proper storage, appropriate packaging, and guaranteed shelf life for fortified foods should be developed. Finally, field trials should be conducted to determine efficacy and effectiveness at the same time as formative research on consumer acceptability. Dr. Bongga concluded that the success of food fortification relies heavily on the active participation of the private food industry with government, providing clear policies and guidelines as well as needed technical assistance.
Mrs. Asuncion L. Macalalag, Acting Executive Director of the National Nutrition Council in the Philippines, discussed the various roles that government should play in getting fortification started and encouraging multisectoral participation based on the Philippine experience.
First, the government’s role is to provide a ripe environment for food fortification. In the case of the Philippines, three major policy instruments guided the start of food fortification: the Philippine Constitution, the Medium-Term Philippine Development Plan, and the Philippine Plan of Action for Nutrition. The latter, in particular, provided food fortification as one of the impact programmes under the plan. Official and unofficial pronouncements by the President of the Philippines and the Secretary of Health expressed support for food fortification. National nutrition surveys by the Food and Nutrition Research Institute supplied scientific information on the extent of micronutrient malnutrition.
Second, the government should initiate action and build momentum for food fortification through advocacy meetings and conferences among government agencies, local government units, non-governmental organizations, business leaders, and food manufacturers. In the Philippines the first advocacy meeting was led by the President himself. This was followed by others, including conferences to which foreign experts were invited to describe their experiences. In all of these advocacy meetings, the private sector figured prominently among the participants. At the same time, technology development and research on the various aspects of food fortification were intensified.
Third, the government maintains the momentum through catalysing and enabling actions to hasten the adoption and implementation of food fortification. In the case of the Philippines, the catalysing and enabling role of government took the form of initially creating the demand for fortified food through public information campaigns, training of producers and traders, soft loans for the acquisition of equipment, passage of the Salt Iodization bill, and instituting the Sangkap Pinoy seal programme through which food manufacturers meeting the requirements for fortification were awarded a seal of approval by the Department of Health. The seal was licensed to be printed on the labels of the fortified food product.
Aside from its advocacy role as the initiator, catalyst, and enabler, government plays coordinative and integrative functions. In the Philippines this function resides with the National Nutrition Council, the highest policy-making and coordinating body for nutrition in the country. To address the problem of micronutrient malnutrition more efficiently, the National Nutrition Council organized the National Micronutrient Action Team, the members of which come from governmental and non-governmental agencies and academic institutions. In addition, the Food Fortification Interagency Committee was formed under the National Micronutrient Action Team, calling for private-sector representatives when needed. Finally, the last role that government should assume is that of a regulator. In assuming this role, the Philippine government has established guidelines for the fortification of foods and is now instituting quality assurance systems to ensure the quality of fortified products in the market.
In assuming all these roles, a major challenge for government is to bring about multisectoral participation. This involves food manufacturers, providers of fortificants, sources of technologies, and those who can promote the consumption of fortified foods, including mass media and consumer organizations.
Mrs. Adelisa C. Ramos, Director of the Nutrition Service of the Department of Health, Philippines, focused on social marketing and advocacy as indispensable ingredients for success in food fortification. Using Philippine experience, particularly with salt iodization, she cited various strategies for social marketing, consisting of communication campaigns, lobbying with legislators, salt industry research, community organization, networking with industry and other sectors, and creation of an organizational structure for programme implementation. The primary targets of the social marketing strategy for iodized salt were mothers. The secondary targets were legislators, local government executives, and health workers. The implementation process of social marketing started with formative research that provided the basis for the campaign, followed by the preparation of a communication plan, the conduct of a Quick Response Survey to determine the strengths and weaknesses of the plan, and finally the implementation of the plan. In fact, a second Communication Plan was implemented on the basis of the results of the first Quick Response Survey. The second Communication Plan resulted in increases in the level of awareness of iodized salt from 66% to 79% and in the level of utilization from 15% to 37% in the areas covered.
Mrs. Ramos also discussed how the Philippines worked for the passage of the Salt Iodization Law, which was passed by Congress and signed by the President in 1996. To sustain the programme, she emphasized the need to promote continued collaboration between the public and private sectors, conduct advocacy meetings, intensify the tri-media campaign, continue education for the programme advocates, provide logistic and technical support to small salt producers, and periodically evaluate the impact of advocacy and social marketing efforts.
Ms. Zahara Merican, of the Malaysian Agricultural Research and Development Institute, cited the case of food fortification in Malaysia. The current Malaysian food regulations address two concerns: mandatory fortification of particular foods, such as fortification of condensed milk and margarine with vitamin A and fortification of iodine with salt in the state of Sarawak; and voluntary fortification of various foods, from bread to snacks- and drinks. The current thinking in Malaysia is to continue to encourage voluntary fortification. Only when advocacy and persuasion fail will regulations be used to address nutritional requirements.
Prof. Pakdee Pothisiri, Secretary General of the Food and Drug Administration in Thailand, emphasized that food-fortification programmes need to be supported by suitable legislation and regulations. The primary purposes of food legislation are to protect the health of the consumer and to protect the consumer from fraud. Procedures for monitoring the premises where fortified foods are prepared, packed, stored, or held for sale, as well as for penalizing defaulters, must be clearly defined. Standards for fortified foods and labelling requirements must also be contained within food regulations. In the light of the Agreement on Technical Barriers to Trade, the development of international standards for fortified foods is an important step in the elimination of technical barriers. Professor Pothisiri further emphasized that food laws are best managed in two parts: the basic food act itself, which sets broad principles, and food regulations, which contain the detailed provisions concerning the different categories of products. This will allow flexibility in the face of new scientific knowledge and technologies.
Dr. Leila G. Saldanha, Nutrition Asia-Pacific Director, Kellogg (Australia), pointed out the need to examine food fortification at three levels in the light of rapid advances in knowledge about nutrients and their role in health promotion and disease prevention. The levels are fortification to treat or prevent nutrient-deficiency diseases, fortification for better nutrition (i.e., fortification of foods to allow achievement of nutritional goals without dramatic dietary changes), and fortification to promote optimum health, which involves levels and combination of nutrients to prevent diseases associated with affluence, such as heart disease, cancer, and cataracts. Finally, Dr. Saldanha underscored the important role of industry in developing technologies to deliver key nutrients to the population. Through innovative partnerships among government, professional groups, private agencies, and the food industry, new technologies can be made available, communication programmes can be developed, and an acceptable regulatory environment can be established.
Dr. Oscar Pineda, of the Latin American Centre for Nutrition and Metabolic Studies (CELANEM), discussed the elements that make up a workable monitoring and evaluation system. Monitoring is done at three levels. First, at the site where premixes are prepared, a daily or lot analysis has to be performed in order to ensure the quality of the premix. At this point, a 5% variation may be expected. Second, at the fortification site, periodic daily quick analyses are required to maintain correct levels of fortification. A larger variation of 15% to 20% is usually found at this stage. Third, at the population consumption level, monitoring should be the responsibility of local health authorities, and an organization should be set up to allow for quick analysis of samples and rapid feedback of results.
Evaluation involves determining the impact on and the level of consumption of the fortified food by the population. In general, an evaluation interval of six months is adequate, as shown by the experience with vitamin A-fortified sugar. In the case of milk and flours fortified with iron bis-glycine chelate, a highly significant effect can be measured in two to three months.
Except at the population level, the organization required for monitoring is essentially that of industry. On the other hand, for evaluation, the organization and facilities of the public health sector are essential to carry out periodic surveys of the impact on representative samples of the population.
Dr. Martin Bloem, Country Director of Helen Keller International in Jakarta, observed that in the last few years there has been a growing emphasis on fortifying foods with vitamin A and improving the diet of the population at risk following the success of vitamin A supplementation programmes in reducing vitamin A deficiency. He cited the cases of Bangladesh, Vietnam, the Philippines, and Indonesia, where distribution of vitamin A capsules has been successful. The problem is the need for guidelines for phasing out the vitamin
A capsule programme and going into fortification and dietary diversification. Dr. Bloem proposed a model for determining whether to phase out vitamin A capsule distribution based on a biomedically sound scientific framework. By doing an effectiveness study on the vitamin A capsule distribution programme, the government can decide whether it needs to continue the programme or go to food fortification and dietary diversification. Monitoring the effectiveness of food fortification can then follow the system for monitoring vitamin A capsule distribution.
Ms. Carmina J. Parce, of the Bureau of Food and Drugs in the Philippines, using the experience with salt iodization in the Philippines, discussed the framework for monitoring universal salt-iodization programmes. The essential elements of internal quality assurance by the producer include purchase of quality raw materials and supplies, validation of the production process, routine inspection of equipment, monitoring of iodine levels in the final product before distribution, and documentation of monitoring protocols and results. External quality assurance is carried out by food regulatory agencies and consists of monitoring products and processes for compliance with requirements for product standards and good manufacturing practices. During inspections, it is essential to verify that the producer is performing internal quality assurance, that records are being maintained, and that appropriate corrective measures are being taken. In addition to monitoring the quality of iodized salt produced in the country, it is essential, at least in the Philippines, where large volumes of salt are imported, that imported salt is also monitored to determine its contribution towards meeting the national iodized salt requirements.
The effectiveness of the salt-iodization programme can be assessed by monitoring at the household level. In the Philippines a community-based salt-monitoring strategy using the school system has been designed to gather data on household levels of consumption of iodized salt. Finally, Ms. Parce described the monitoring system for the Sangkap Pinoy seal programme in the Philippines, which is intended to encourage voluntary fortification of foods with vitamin A, iron, and iodine by food manufacturers. A technical board first determines whether the criteria to qualify for the seal are satisfied by the manufacturer. After the seal has been granted, monitoring activities consist of periodic assessment of the company’s quality management system, evaluation of monitoring data on claimed fortificant levels, and review of promotion materials. A network of government and private laboratories has been identified by the Bureau of Food and Drugs to provide analytical services.
Mr. Ricardo M. Dizon, Quality Control Section Manager of the Philippine Dairy Products Corporation, described the monitoring and evaluation system that his company employs in fortifying margarine with vitamin A. To fully satisfy the criteria for a successful food-fortification programme, the following must be taken into consideration: vitamin A potency and safety as per label and copy claims (the predetermined level of vitamin A should be maintained, with consideration given to expected shelf life, and the right kind and amount of antioxidants should be used); affordability and accessibility of the product through a reasonable price and an aggressive marketing network; strict quality control measures at the plant; and monitoring of vitamin A activity in trade samples (quarterly monitoring in supermarkets and retail stores, including those in far-flung areas, is recommended).
