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REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION IN SOUTHEAST ASIA ILSI SOUTHEAST ASIA REGION REPORT SERIES

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Page 1: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

http://www.ilsi.org/SEA_Region

REGIONAL OFFICE:ILSI SOUTHEAST ASIA REGION9 Mohamed Sultan Road #02-01, Singapore 238959Tel: 65 6352 5220 Fax: 65 6352 5536 Email: [email protected]

COUNTRY OFFICE & COMMITTEES:Australasia • Indonesia • Malaysia • Philippines • Thailand

R E P O RT O N R E G U L ATO RY S TAT U S O F M I C R O N U T R I E N T F O RT I F I C AT I O N I N S O U T H E A S T A S I A

I L S I S O U T H E A S T A S I A R E G I O N R E P O RT S E R I E S

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The International Life Sciences Institute (ILSI) is a non-profit, worldwide foundation based in Washington, DC, USA established in 1978 to advance the understanding of scientific issues relating to nutrition, food safety, toxicology, risk assessment and the environment. ILSI accomplishes its work through its branches and the ILSI Research Foundation.

Established in 1993, ILSI Southeast Asia Region facilitates and coordinates scientific programs, research and information dissemination in Southeast Asia, Australia, New Zealand and the Pacific Islands. Based in Singapore, ILSI Southeast Asia Region also oversees a Country Office in Australia and Country Committees in Indonesia, Malaysia, Philippines and Thailand.

By bringing together scientists from academia, government, industry and the public sector, ILSI seeks a balanced approach to solving problems of common concerns for the health and well-being of the general public. ILSI receives financial support from industry, government, and foundations.

This publication, published in December 2011, is made possible with the support of the ILSI Southeast Asia Region Food Fortification Task Force. The Task Force facilitates data collection on food fortification programs and regulations in the Southeast Asian countries. It also facilitates research on fortification technologies, as well as the evaluation of effectiveness and safety of fortification programs in collaboration with national research institutions and regulatory agencies in Southeast Asia, and the ILSI Center for Health Promotion.

Copyright © 2011 International Life Sciences Institute (ILSI)

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means,

electronic, mechanical, photocopying or otherwise, without the prior permission of the copyright owners.

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REPORT ON REGULATORY STATUS

OF MICRONUTRIENT FORTIFICATION

IN SOUTHEAST ASIA

AuthorsMia Isabelle, Pauline Chan, Steffiana Y. Wijaya

International Life Sciences Institute Southeast Asia Region Report Series

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Table of Contents

1. Background ........................................................................................................................................................................................3 1.1. Definition and Purpose of Fortification 1.2. Recommendations and Regulations of Micronutrient Fortification 1.3. ILSI Southeast Asia Region: Fortification Programs

2. Survey on Status of Micronutrient Fortification Regulations ...................................................................................................4 2.1. Survey’s Scope and Methodology

3. Summary of Survey Findings on Micronutrient Fortification Regulations .............................................................................4 3.1. By Country ..................................................................................................................................................................................4 3.1.1. Brunei Darussalam 3.1.2. Indonesia 3.1.3. Malaysia 3.1.4. The Philippines 3.1.5. Singapore 3.1.6. Thailand 3.1.7. Vietnam 3.1.8. Cambodia, Laos, Myanmar 3.2. By Nutrient .................................................................................................................................................................................6 3.2.1. Iodine 3.2.2. Iron 3.2.3. Vitamin A 3.2.4. Folic Acid and B Vitamins 3.2.5. Zinc 3.2.6. Other Vitamins and Minerals

4. Summary of Survey Findings on Monitoring and Evaluation Processes .................................................................................7

5. Conclusion and Recommendations .................................................................................................................................................7

6. References ........................................................................................................................................................................................8

7. List of Tables Table 1A. Salt Iodization in SEA .....................................................................................................................................................9 Table 1B. Regulatory Status of Claims on Iodine Fortification in SEA ......................................................................................10 Table 2A. Iron Fortification Programs in SEA ..............................................................................................................................11 Table 2B. Regulatory Status of Claims on Iron Fortification in SEA ..........................................................................................12 Table 3A. Vitamin A Fortification Programs in SEA ....................................................................................................................13 Table 3B. Regulatory Status of Claims on Vitamin A Fortification in SEA ................................................................................14 Table 4A. Folic Acid and B Vitamins Fortification Programs in Southeast Asia .......................................................................15 Table 4B. Regulatory Status of Claims on Folic Acid and B Vitamins Fortification in Malaysia ..............................................16 Table 4C. Regulatory Status of Claims on Folic Acid and B Vitamins Fortification in Singapore ...........................................17 Table 4D. Regulatory Status of Claims on Folic Acid and B Vitamins Fortification in Brunei,

Indonesia and Thailand................................................................................................................................................18 Table 5. Zinc Fortification Programs and Regulatory Status of Claims on Zinc Fortification in

Southeast Asia ..............................................................................................................................................................19 Table 6A. Voluntary Fortification Programs with Other Vitamins and Minerals in the Philippines .........................................20 Table 6B. Voluntary Fortification Programs with Other Vitamins and Minerals in Brunei Darussalam ..................................21 Table 6C. Regulatory Status of Claims on Other Vitamins and Minerals Fortification in Indonesia.......................................22 Table 6D. Regulatory Status of Claims on Other Vitamins and Minerals Fortification in Malaysia ........................................23 Table 6E. Regulatory Status of Claims on Other Vitamins and Minerals Fortification in Singapore ......................................24 Table 6F. List of Other Vitamins and Minerals Permitted for Fortification Claims in Thailand (Unofficial Translation) .......25 Table 7A. Monitoring and Evaluation of Mandatory Fortification Programs in Cambodia,

Indonesia and Malaysia................................................................................................................................................26 Table 7B. Monitoring and Evaluation of Mandatory and Voluntary Fortification Programs in the Philippines .....................27 Table S1. Minimum Amounts of Nutrients for Fortification Claims in Malaysia .....................................................................28

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1. Background

Micronutrient malnutrition presents a public health problem in some industrialized nations, but even more so in the developing regions of the world (WHO & FAO, 2006). Deficiencies in iron, vitamin A and iodine are the most prevalent worldwide. Together, these micronutrient deficiencies affect at least one third of the world’s population, the majority of who are in developing countries.

Policy and program responses to micronutrient malnutrition include (a) food-based strategies such as dietary diversification and food fortification, (b) nutrition education, public health and food safety measures, as well as (c) supplementation (WHO & FAO, 2006). Dietary diversification through nutrition education has been the foundation of long-term strategies, but its implementation may be relatively time-consuming, given a lack of resources and education, and difficulties in changing food habits. Micronutrient supplementation often results in rapid improvements in the micronutrient status of target groups; however, supplementation approaches have faced problems of cost, poor compliance, and inefficient delivery of supplements. Food fortification, on the other hand, tends to have a less immediate but nevertheless a much wider and more sustained impact. Micronutrient fortification of commonly consumed foods, such as staples and condiments, has been shown to be a cost-effective strategy for the control of micronutrient malnutrition in the medium and long-term (WHO & FAO, 2006).

1.1. Definition and Purpose of Fortification

According to the Codex General Principles for the Addition of Essential Nutrients to Foods, fortification or enrichment is defined as “the addition of one or more essential nutrients to a food whether or not it is normally contained in the food for the purpose of preventing or correcting a demonstrated deficiency of one or more nutrients in the population or specific population groups” (Codex Alimentarius, 1991). The Codex General Principles further states that fortification should be the responsibility of national authorities since the kinds and amounts of essential nutrients to be added and foods to be fortified will depend upon the particular nutritional problems to be corrected, the characteristics of the target populations, and the food consumption patterns of the area.

Conditions for the fulfillment of any fortification program include: (a) a demonstrated need for increasing the intake of an essential nutrient in one or more population groups, either through actual clinical or subclinical evidence of deficiency, estimates indicating low levels of intake of nutrients, or possible deficiencies likely to develop because of changes taking place in food habits; (b) the food selected as a vehicle should be consumed by the population at risk; (c) the intake of the food vehicle should be stable and uniform with known lower and upper levels of intake; (d) the amount of the essential nutrient added to the food should be sufficient to correct or prevent the deficiency when the food is consumed in normal amounts by the population at risk but also not result in excessive intakes by individuals with a high intake of a fortified food (Codex Alimentarius, 1991).

WHO and FAO Guidelines on Food Fortification with Micronutrients offers a wider perspective on the definition of food fortification – “the practice of deliberately increasing the content of essential micronutrients (vitamins and minerals including trace elements) in a food so as to improve the nutritional quality of the food supply and to provide a public health benefit with minimal risk to health”. The public health benefits of fortification may be either demonstrable, or indicated as potential or plausible by generally accepted scientific research, and include: (a) prevention, risk minimization or contribution to the correction of occurrence of micronutrient deficiency in a population or specific population groups; (b) a potential for improving nutritional status and dietary intakes that may be, or may become, suboptimal as a result of changes in dietary habits/lifestyles; and (c) plausible beneficial effects of micronutrients consistent with maintaining or improving health (WHO & FAO, 2006).

1.2. Recommendations and Regulations of Micronutrient Fortification

The World Health Organization (WHO) and Food and Agriculture Organization of the United Nations (FAO) have extensively reviewed the best recommendations for food fortification, and have provided specific technical advice as indicated (WHO and FAO, 2006). For instance, WHO and FAO have issued specific recommendations for the fortification of flour due to its wide consumption (WHO et al, 2009). Flour is a food vehicle especially important for the fortification of iron, which is seen as the micronutrient most associated with deficiency. An expert panel recently noted that many fortification programs of flour with iron have not significantly reduced iron deficiency, often due to the low bioavailability of the iron compound (Hurrell et al, 2010). Compliance with the WHO-FAO guidelines (which incorporate the expert panel recommendations) increases the likelihood of measurable reductions in micronutrient deficiencies. According to WHO-FAO (2006), fortification provisions in food law should ensure that all compositional parameters applicable to both fortificants and food vehicles deliver safe and appropriately efficacious public health outcomes, and that the labeling and claims of fortified foods are factual, and provide sufficient information to enable appropriate consumption.

The scope of regulatory provisions related to fortification may, however, differ from country to country. Some countries adopt mandatory and voluntary fortification regulations as part of an overall nutrition policy to address certain nutrient deficiencies that may be a cause of concern. On the other hand, other countries may regulate voluntary fortification of nutrients without having explicit nutrient deficiency eradication goals; rather, regulation of voluntary fortification intends to make permissible the increment of nutrient levels in the fortified food, in comparison with the naturally-occurring amount. Regulations are set to control the claims on the nutrient content of these fortified foods.

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1.3. ILSI Southeast Asia Region: Fortification Programs

Over the past 15 years, the International Life Sciences Institute (ILSI) Southeast Asia (SEA) Region has been involved in addressing issues and challenges in micronutrient deficiencies in the region. In 1996, it organized the Regional Conference on Food Fortification in cooperation with the Philippines national authorities, which prompted the Manila Declaration calling for a multisectoral partnership to control micronutrient deficiencies through food fortification.

From 2000 to 2004, ILSI SEA Region collaborated with international bodies such as the United Nations and the United Nations Children’s Fund (UNICEF), as well as regional organizations such as the Asian Development Bank, to facilitate a series of workshops to address food fortification strategies to combat micronutrient deficiencies in both adults and young children in SEA.

As part of ILSI’s global Project IDEA (Iron Deficiency Elimination Action), which aims to reduce iron deficiency anemia in developing countries by adding iron to foods such as staples and condiments, ILSI SEA Region has been working with ILSI Japan Center for Health Promotion on food fortification programs in Cambodia, the Philippines and Vietnam since 2005. Fish-sauce has been fortified with iron in Vietnam, while iron-fortified rice has been tested in the Philippines, and both fish-sauce and soy-sauce have been fortified with iron in Cambodia.

2. Survey on Status of Micronutrient Fortification Regulations

With the implementation of programs for micronutrient fortification of staples and condiments, national authorities across SEA have developed regulations that require mandatory fortification of certain nutrients, and voluntary fortification of others. The scope and extent of fortification policies and programs, as well as national regulations governing fortification, vary significantly throughout the region.

To assist all stakeholders – including national bodies and regulators, industry, researchers and scientists across Southeast Asia to better understand the status of food fortification programs and regulations in the region, ILSI SEA Region conducted a year-long survey on the regulatory status of mandatory and voluntary fortification of micronutrients in Southeast Asia region, particularly those involving staple foods and condiments. The information gathered through this survey will help to identify some of the gaps for prioritization of future activities in this area; it is hoped that the survey findings will be useful to stakeholders in planning and implementation of food fortification strategies within and between SEA countries.

2.1. Survey’s Scope and Methodology

This survey considered three types of fortification regulations: (a) those related to addressing nutrient deficiencies; (b) those related to voluntary addition of nutrients; and (c) those related to nutrient content claims. Regulations for targeted

fortifications e.g. those targeting infants and young children were not included in this survey.

A survey form setting out information on relevant regulations, obtained through published regulation documents and references, was circulated to the regulatory agencies of 10 SEA Region countries:

• Brunei Darussalam • Cambodia• Indonesia • Laos• Malaysia • Myanmar• The Philippines • Singapore• Thailand • Vietnam

The survey was sectioned into three parts: (a) respondent detail; (b) survey form on the regulatory status of various nutrients; and (c) the monitoring and evaluation of these voluntary or mandatory regulations. For each nutrient included in the survey, the survey requested for information on:

• Fortificant• Food Vehicle• Status (Mandatory / Voluntary)• Minimum Acceptable Level• Maximum Tolerable Level• Labeling Requirement (e.g. logo/symbol)• Nutrient Content Claims Permitted & Conditions for Claim• Nutrient Comparative Claims Permitted & Conditions

for Claim• Nutrient Function Claims Permitted & Condition

for Claim• Disease Risk Reduction Claims Permitted & Conditions

for Claim• Regulating Body• Regulation Name• Issue Date

Regulators were requested to verify the information pertaining to food fortification regulations stated in the survey, as well as to provide any updates and additional information on other micronutrients and their monitoring and evaluation systems, where available. As of July 2011, the final confirmation of the report has been obtained from the National Agency for Drug and Food Control (BPOM), Indonesia, the Agri-Food and Veterinary Authority (AVA), Singapore, and the Thai Food and Drug Administration (FDA).

Information about the addition of nutrient supplements, claims on fortifications, and other relevant information pertaining to the regulations have been included in this report as well.

3. Summary of Survey Findings on Micronutrient Fortification Regulations

3.1. By Country

3.1.1. BruneiDarussalam

No mandatory fortification regulation has been instituted.

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However, the country’s Public Health (Food) Act (Chapter 182) states provisions for the addition of nutrient supplements, which are defined as any amino acid, mineral or vitamin which, when added either singly or in combination with food, improves or enriches the nutrient content of food. The list of permitted nutrient supplements is available in the Twelfth Schedule of the Act (Attorney General's Chamber Brunei Darussalam, 2001). Provisions of voluntary fortification claims allow products to bear fortification claims when a specified reference quantity of the fortified food contains not less than a half of the daily allowance of the fortificant. The RDA value of the vitamins (including vitamin A, C, D and E, B vitamins and folate) and minerals (including iodine, iron, calcium and phosphorus) as well as the reference quantity for each food category is specified in its Food Act (Attorney General's Chamber Brunei Darussalam, 2001).

3.1.2. Indonesia

Regulatory authorities stipulate mandatory fortification of salt with iodine (Ministry of Industry, Republic of Indonesia, 2005) and mandatory fortification of wheat flour with iron, zinc, folic acid, vitamins B1 and B2 (Ministry of Health, Republic of Indonesia, 2003; Ministry of Industry, Republic of Indonesia, 2011).

Provisions of voluntary micronutrient fortification claims in food products are that products are only allowed to bear fortification claims when the fortified food contains an increased level of vitamins or minerals of not less than 10% of the Indonesian recommended daily allowance (AKG) as compared to the reference food (BPOM, Indonesia, 2005).

The nutrients with specified provisions for voluntary fortification claims include vitamins A, C, D, E, K, B vitamins and folate, as well as minerals including iron, potassium, calcium, magnesium, manganese and selenium. The AKG value for use in nutrition labeling differs for the general consumer and for infants, children, and pregnant and lactating women (BPOM, Indonesia, 2007).

3.1.3. Malaysia

Mandatory fortification of salt with iodine is instituted in certain regions of Malaysia.

The country’s Food Regulations 1985 also states provisions for the addition of nutrient supplements, which refer to any mineral, vitamin, essential amino acid or essential fatty acid which, when added either singly or in combination to food, improves or enriches the nutrient content of food. The list of permitted nutrient supplements is available in the Twelfth Schedule (Legal Research Board, 2009).

Provision of voluntary fortification claims states the minimum amounts of nutrient that need to be provided by the fortified food, depending on the food category (Table S1). The maximum amount of each nutrient in terms of intake units per day is also stipulated in the regulation (Legal Research Board, 2009). The nutrients with specified provisions for voluntary fortification claims include vitamins A, C, D, E, B vitamins and folate, as well as minerals including iron, calcium and phosphorus.

3.1.4. ThePhilippines

The Philippines’ Guidelines on Micronutrient Fortification of Processed Foods, define fortification as “the addition of nutrients to processed foods or food products at levels above the natural state. As an approach to control micronutrient deficiency, food fortification is addition of a micronutrient, deficiency in the diet, to a food which is widely consumed by specific at-risk groups”. The Guidelines were set in recognition of the nutritional deficiency problems observed through a nutrition survey in the Philippines. The deficiencies include energy, iron, vitamin A, thiamin, and riboflavin, as well as ascorbic acid, calcium and folate to a minor extent (FDA Philippines, 1995).

The government stipulates mandatory fortification of rice with iron, salt with iodine, wheat flour with iron and vitamin A, refined sugar with vitamin A, and cooking oil (except those for export) with vitamin A.

The Philippines FDA also regulates voluntary fortification of micronutrients and its claim by stating the minimum nutrient content of the fortified food, depending on the deficiency status of the particular nutrient in the Filipino diet, the establishment of its Recommended Daily Allowance (RDA), level of toxicity, etc (FDA Philippines, 1995; FDA Philippines, 2000). The RDA value for each nutrient is provided in the regulation.

The nutrients with specified provisions for voluntary fortification claims include vitamins A, C, D, E K, B vitamins and folate, iron, potassium, calcium, copper, magnesium, manganese and selenium.

3.1.5. Singapore

No mandatory fortification regulation has been instituted. However, the country’s Sale of Food Act (Chapter 283) Food (Amendment) Regulations 2011 states provisions for addition of nutrient supplements, which are defined as “any amino acid, mineral or vitamin, which when added either singly or in combination with food, improves or enriches the nutrient content of food.” The list of permitted nutrient supplements is available in the Seventh Schedule (AVA, Singapore, 2011). Provision of voluntary fortification claims states that the fortified food per specified reference quantity is required to contain at least 50% of the daily allowance of the nutrient. The Recommended Daily Allowance (RDA) value of vitamins (including vitamins A, C, D, B vitamins and folate) and minerals (including iodine, iron, calcium and phosphorus) as well as the reference quantity of each food category is specified in the regulation (AVA, Singapore, 2010).

3.1.6. Thailand

The Thai FDA stipulates mandatory fortification of salt with iodine, condensed milk and margarine with vitamin A, and vitaminized rice with vitamins B1, B2 and B3 (FDA, Thailand, 1993, 2000 & 2002).

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Provisions of voluntary fortification claims states that products are only allowed to bear fortification claims when they contain increased levels of vitamins or minerals of not less than 10% of the Thai Recommended Daily Intake (RDI), as compared to the reference food (FDA, Thailand, 1998). It is also stipulated that the RDI value for Thais of ages 6 years and up is to be used as criteria for displaying of nutrition value on food labels. The nutrients with specified provisions for voluntary fortification claims include vitamins A, C, D, E, K, B vitamins and folate, iron, zinc, calcium, phosphorus, magnesium, copper, potassium, manganese, selenium, fluoride, molybdenum, chromium and chloride.

3.1.7. Vietnam

Regulatory authorities stipulate mandatory fortification of salt with iodine (Flour Fortification Initiative, 2009). The Ministry of Health launched the Technical Regulation No. 6289/2003/QD-BYT on Food Fortification which provides guidance on the specifications and level of fortificants for voluntary fortification of certain foods – including wheat flour with iron, folic acid, zinc, thiamine and riboflavin, fish sauce with iron, and sugar and vegetable oil with vitamin A (Dao & Huong, 2008).

3.1.8. Cambodia,Laos,Myanmar

Universal salt iodization is the only known provision made on fortification in these countries (UNICEF & FFI).

3.2. By Nutrient

3.2.1. Iodine

Iodization of salt remains the most common mandatory fortification in SEA Region, except in Singapore, Brunei Darussalam, and certain parts of Malaysia. Regulation of salt iodization programs in Southeast Asia, including minimum acceptable levels and maximum tolerable levels, is shown in Table 1A.

Thailand recently gazetted mandatory iodization of fish sauce, hydrolyzed/fermented soy sauce, and brine for cooking, with minimum and maximum levels of 2 mg/l and 3 mg/l, respectively, for fortification using potassium iodate.

The Philippines also regulates voluntary fortification of processed foods that contain at least 40 kilocalories per normal serving with iodine at minimum and maximum levels of 33% and 150% of the RDA for the target consumers, respectively.

The provisions for fortification claims on iodine in countries including Brunei, Indonesia, Malaysia, Singapore and Thailand are shown in Table 1B. The detailed stipulations for claims on fortification of specific food types with iodine in Malaysia are shown in Table S1.

3.2.2. Iron

Regulation of iron fortification programs is shown in Table 2A. Fortification of wheat flour is mandatory in Indonesia and the Philippines, and voluntary in Vietnam.

The Philippines FDA also mandates iron fortification of rice (except brown rice and locally produced glutinous rice). Staple foods fortified with iron at the stipulated levels are eligible for the Diamond Sangkap Pinoy Seal logo in the Philippines. The Philippines FDA also regulates voluntary fortification of processed foods that contain at least 40 kilocalories per normal serving; products which meet the fortification requirements are eligible for the Sangkap Pinoy Seal logo as well.

Regulatory authorities in Vietnam regulate the voluntary iron fortification of fish sauce.

The provisions for fortification claims on iron in countries including Brunei, Indonesia, Malaysia, Singapore and Thailand are shown in Table 2B. The detailed stipulations for claims on fortification of specific food types with iron in Malaysia are shown in Table S1.

3.2.3. VitaminA

Regulation of vitamin A fortification programs in SEA is shown in Table 3A. The Thai FDA implements mandatory vitamin A fortification of condensed milk and margarine. The Philippines FDA also implements mandatory vitamin A fortification of wheat flour, refined sugar and cooking oil.

The Philippines FDA states provisions for voluntary fortification of processed foods with vitamin A and beta carotene. Additionally, the Vietnamese Ministry of Health regulates voluntary fortification of sugar and vegetable oil.

The provisions for fortification claims on vitamin A in countries including Brunei, Indonesia, Malaysia, Singapore and Thailand are shown in Table 3B. The detailed stipulations for claims on fortification of specific food types with vitamin A in Malaysia are shown in Table S1.

3.2.4.FolicAcidandBVitamins

Regulation of B vitamins fortification programs is shown in Table 4A. The Indonesian BPOM stipulates mandatory fortification of wheat flour with folic acid, vitamin B1, and vitamin B2. The Vietnamese Ministry of Health stipulates regulations for voluntary fortification of wheat flour as well.

The Philippines FDA states provisions for voluntary fortification of processed foods with B vitamins, while the Thai FDA states provisions for mandatory fortification of vitaminized rice. The provisions for fortification claims on folic acid and B vitamins in Malaysia, Singapore, and Brunei, Indonesia and Thailand, are shown in Tables 4B, 4C and 4D, respectively. The detailed stipulations for claims on fortification of specific food types with B vitamins in Malaysia are shown in Table S1.

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3.2.5. Zinc

Regulation of zinc fortification programs is shown in Table 5. Wheat flour fortification with zinc in Indonesia is mandatory, while that in Vietnam is voluntary.

The Philippines FDA regulates voluntary fortification of processed foods with zinc.

Regulatory authorities in Indonesia and Thailand state provisions for fortification claims on zinc as well.

3.2.6. OtherVitaminsandMinerals

Provisions for voluntary fortification of all other vitamins and minerals in the Philippines (Table 6A), Brunei (Table 6B), Indonesia (Table 6C), Singapore (Table 6E) and Thailand (Table 6F) are shown in the respective tables.

Provisions for voluntary fortification of other vitamins and minerals in Malaysia are shown in Table 6D, and the minimum amounts of nutrients for fortification claims are shown in Table S1.

These micronutrients include vitamins C, D, E and K, as well as calcium, chloride, chromium, copper, fluoride, magnesium, manganese, molybdenum, phosphorus, potassium and selenium.

4. Summary of Survey Findings on Monitoring and Evaluation Processes

Monitoring is crucial to ensure compliance with the stipulated regulations on micronutrient fortification. Since governments have a vital role in ensuring public health, compliance with food fortification regulations, as well as the effective implementation of food fortification programs need to be monitored and evaluated continuously to ensure maximum benefits to target groups and the safety of all consumers (WHO & FAO, 2006). External monitoring by governmental food control authorities should combine technical auditing (checking the performance and the records of the producers’ quality assurance procedures) and inspection (confirming that the technical specifications for the products are being met at factories, packaging sites, and points of entry into the country). These procedures can be added to existing food safety regimes. It would be necessary to verify whether the monitoring systems are actually being implemented, and to understand the levels of compliance to the regulations. Only Cambodia, Indonesia, Malaysia and the Philippines have provided information on their monitoring systems as seen in Table 7A and Table 7B.

Impact evaluation is also crucial to determine whether or not the food fortification regulations and programs have achieved their objectives of improving the nutritional status of the target populations (WHO & FAO, 2006). Impact

evaluation is, however, rarely performed as it is perceived to be complex and costly. Most of the countries do not have such evaluation processes, and do not conduct reviews of the effectiveness of their regulations.

The actual status of micronutrient deficiencies is not well established in many SEA population segments. It is often not a standard practice to check for these deficiencies in routine medical examinations; in the case of pregnant women, anemia will be measured but not true iron deficiency. It is important to establish a well-grounded basis for estimating the actual micronutrient deficiencies in the target populations.

5. Conclusion and Recommendations

Salt iodization, iron and vitamin A fortification in staples are the most common forms of mandatory fortification in the Southeast Asia region. Zinc and B vitamins fortification are also mandatory in some countries. Most countries have individual regulations on voluntary fortification with various vitamins and minerals. The stipulated fortification amounts, fortification vehicles, as well as the level of regulation differ from one country to another in varying degrees, creating a complex regulatory landscape.

Monitoring compliance is crucial to ensure maximum benefit to target groups and safety of all consumers, while evaluation is needed to assess the impact of fortification on the nutritional status of the target populations; addressing these two aspects within the SEA context would be crucial for fortification regulations and programs to achieve their intended purpose.

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Food and Drug Administration Thailand. (2000). NotificationoftheMinistryofPublicHealthNo.207/2543(2000)Margarine. Retrieved from: http://www.qmaker.com/fda/new/images/cms/top_upload/1147229817_207-43%20Margarine_update_.pdf

Food and Drug Administration Thailand. (2002). NotificationoftheMinistryofPublicHealthNo.265/2545(2002)Cow’sMilk. Retrieved from: http://www.qmaker.com/fda/new/images/cms/top_upload/1148400308_265-45(1).pdf

Food and Drug Administration Philippines. (1995). AdministrativeOrderNo.4-As.1995,GuidelinesonMicronutrientFortificationofProcessedFoods. Retrieved from: http://www.bfad.gov.ph/pdf/RegulatoryGuidance/food/ao/AO4-As1995.pdf

Food and Drug Administration Philippines. (1995). RepublicActNo.8172,AnActforSaltIodizationNationwide. Retrieved from: http://www.bfad.gov.ph/oldsite/republic%20acts/RA%208172%20-%20Asin%20Law.pdf

Food and Drug Administration Philippines. (2000). RepublicActNo.8976,PhilippineFoodFortificationActof2000. Retrieved from: http://www.doh.gov.ph/ra/ra8976

Hurrell R, Ranum P, de Pee S, Biebinger R, Hulthen L, Johnson Q, Lynch S. (2010). Revisedrecommendationsforironfortificationofwheatflourandanevaluationoftheexpectedimpactofcurrentnationalwheatflourfortificationprograms. Food Nutr Bull., 31(1 Suppl): S7-21. Iodine Network. CountryProfile:Vietnam. Retrieved from: http://www.iodinenetwork.net/countries/Vietnam.htm

Legal Research Board. (2009). FoodAct1983(Act281)&Regulations. Malaysia: International Law Book Services.Ministry of Health, Republic of Indonesia. (2003). MinistryofHealthDecreeNo1452/MENKES/SK/X/2003,WheatFlourFortification. Retrieved from: http://www.depkes.go.id/downloads/Sk1452-03.pdf

Ministry of Industry, Republic of Indonesia. (2011). MinistryofIndustryDecreeNo.35/M-IND/PER/3/2011,MandatoryEnforcementofIndonesianNationalStandardsofWheatFlourasFoodSubstance. Retrieved from: http://sisni.bsn.go.id/index.php?/sni_main/sni_amand/unduh2/9640

National Agency for Drug and Food Control, Republic of Indonesia. (2005). Functionalfood. Retrieved from: http://pom.go.id/public/hukum_perundangan/pdf/SK%20PanFUNGSI%20.pdf

National Agency for Drug and Food Control, Republic of Indonesia. (2007). ReferenceValueforNutritionLabelingofFood. Retrieved from: http://aimi-asi.org/wp/wp-content/files/bpom/AcuanLabelGizi.bpom2007.pdf

President of Republic of Indonesia. (1994). PresidentDecreeNo69Year1994,IodizedSaltProcurement. Retrieved from: http://legislasi.mahkamahagung.go.id/docs/KEPPRES/KEPPRES_1994_69_PENGADAAN%20GARAM%20BERYODIUM.pdf

UNICEF & FFI. NutritionandFoodFortificationStatusinParticipatingCountries. Retrieved from: http://www.unicef.org/eapro/FFI_Regional_Participating_countries_fact_sheet.pdf

WHO and FAO. (2006). Guidelinesonfoodfortificationwithmicronutrients. Retrieved from: http://www.who.int/nutrition/publications/guide_food_fortification_micronutrients.pdf

WHO, FAO, UNICEF, GAIN, MI, & FFI. (2009). Recommendationsonwheatandmaizeflourfortification.MeetingReport:InterimConsensusStatement. Retrieved from: http://www.who.int/nutrition/publications/micronutrients/wheat_maize_fort.pdf

Page 11: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

9

Cam

bo

dia

Ind

one

sia

Lao

sM

alay

sia

Mya

nmar

Phi

lipp

ines

Thai

land

Vie

tnam

Fort

ifica

ntPo

tass

ium

iod

ate,

So

diu

m io

did

e,

Pota

ssiu

m io

did

e

Pota

ssiu

m io

dat

ePo

tass

ium

iod

ate

Pota

ssiu

m io

dat

e,

Pota

ssiu

m io

did

e,

Sod

ium

iod

ate,

So

diu

m io

did

e

Pota

ssiu

m io

dat

ePo

tass

ium

iod

ate

Pota

ssiu

m io

dat

ePo

tass

ium

iod

ate

Foo

d V

ehic

leSa

ltE

dib

le s

alt

for

hum

an

cons

ump

tion

Salt

Salt

Salt

for

hum

an

and

ani

mal

co

nsum

ptio

n

Foo

d-g

rad

e sa

lt fo

r hu

man

or

anim

al

cons

ump

tion

Ed

ible

sal

t, e

xcep

t th

ose

man

ufac

ture

d fo

r ex

po

rt

Ed

ible

sal

t fo

r hu

man

co

nsum

ptio

n

Stat

usM

and

ato

ryM

and

ato

ryM

and

ato

ryM

and

ato

ry fo

r ce

rtai

n re

gio

ns in

Mal

aysi

aM

and

ato

ryM

and

ato

ryM

and

ato

ryM

and

ato

ry

Min

imum

A

ccep

tab

le L

evel

50-6

0 m

g/k

g a

t th

e p

rod

ucer

leve

l; 30

-60

mg

/kg

at

the

reta

il le

vel

30 m

g/k

g40

-60

mg

/kg

at

the

fact

ory

leve

l an

d

>20

mg

/kg

at

the

hous

eho

ld le

vel

-40

mg

/kg

in t

he p

lant

; 15

mg

/kg

in h

ous

eho

ld20

mg

/kg

30 m

g/k

g20

mg

/kg

at

the

ho

useh

old

leve

l

Max

imum

To

lera

ble

Lev

el-

--

200m

cg /

day

-70

mg

/kg

100

mg

/kg

-

Lab

elin

g

Req

uire

men

t (e

.g.

log

o/s

ymb

ol)

-SN

I mar

k-

--

Dia

mo

nd

Sang

kap

Pin

oy

Seal

for

Stap

les

--

Nut

rien

t C

ont

ent

and

Co

mp

arat

ive

Cla

im P

erm

itte

d

-Ye

s-

Yes,

follo

w C

OD

EX

-Ye

s, fo

llow

CO

DE

X,

crite

ria b

ased

on

Phili

pp

ines

RE

NI

Yes,

form

at s

imila

r to

C

od

ex, c

riter

ia b

ased

o

n Th

ai R

DI

-

Nut

rien

t Fu

ncti

on

Cla

im P

erm

itte

d-

Yes

-E

ssen

tial f

or

the

fo

rmat

ion

of

thyr

oid

ho

rmo

ne

Co

nditi

ons

: m

eet

the

crite

ria fo

r “s

our

ce o

f” c

laim

-Ye

s, fo

llow

CO

DE

XU

noffi

cial

tra

nsla

tion:

an

inte

gra

l par

t o

f the

th

yro

id h

orm

one

s w

hich

re

gul

ate

gro

wth

and

d

evel

op

men

t o

f bo

dy

and

bra

in

func

tions

-

Dis

ease

Ris

k R

educ

tio

n C

laim

P

erm

itte

d

-N

ot

per

mitt

ed-

No

t p

erm

itted

-Ye

s, fo

llow

CO

DE

XN

ot

per

mitt

ed-

Reg

ulat

ing

bo

dy

Min

istr

y o

f C

om

mer

ceM

inis

try

of I

ndus

try

Foo

d a

nd D

rug

D

epar

tmen

t o

f Min

istr

y o

f Hea

lth

Foo

d S

afet

y an

d

Qua

lity

Div

isio

n -

Min

istr

y o

f Hea

lth

Mal

aysi

a

Mya

nmar

Sal

t an

d

Mar

ine

Che

mic

als

Ent

erp

rise

of t

he

Min

istr

y o

f Min

es

Dep

artm

ent

of H

ealth

th

roug

h Fo

od

and

Dru

g

Ad

min

istr

atio

n (F

DA

) Ph

ilip

pin

es

Foo

d a

nd D

rug

A

dm

inis

trat

ion

Min

istr

y o

f Hea

lth

Reg

ulat

ion

Nam

e/D

ate

-Sub

-Dec

ree

No

.69,

M

anag

emen

t o

f Io

diz

ed S

alt

Exp

loita

tion

(20-

Oct

-93)

- Jo

int-

PRA

KA

S O

n Th

e M

anag

emen

t

Pro

ced

ures

of A

ll K

ind

of I

od

ized

Sal

t E

xplo

itatio

n (2

-Jul

-04)

Min

istr

y o

f Hea

lthR

egul

atio

n o

f the

M

inis

ter

of

Ind

ustr

y N

umb

er 4

2/M

-IN

D/P

ER

/ 11

/20

05 Y

ear

2005

on

Pro

cess

ing

, Pac

kag

ing

an

d L

abel

ing

of

Iod

ized

Sal

t (2

9 N

ove

mb

er 2

005)

Prim

e M

inis

ter’s

D

ecre

e o

n U

nive

rsal

Sal

t Io

diz

atio

n

(1-M

ay-9

5)

- -Foo

d A

ct 1

983

(Act

281

) and

R

egul

atio

ns 1

985

Gui

de

to

Nut

ritio

n La

bel

ing

an

d C

laim

s as

at

Dec

emb

er 2

007

Prim

e M

inis

ter’s

D

ecre

e o

n U

nive

rsal

Sal

t Io

diz

atio

n (1

-May

-95)

- - -Rep

ublic

Act

N

o. 8

172,

An

Act

for

Salt

Iod

izat

ion

Nat

ionw

ide

(20-

Dec

-95)

BC

200

7-00

9,

Up

dat

ed S

tand

ard

s fo

r Io

din

e Le

vel o

f Sal

ts

(10-

Oct

-07)

Bur

eau

Circ

ular

20

07-0

02, G

uid

elin

es in

th

e U

se o

f Nut

ritio

n an

d

Hea

lth C

laim

s in

Fo

od

(2

3-Ja

n-07

)

No

tifica

tion

of

Min

istr

y o

f Pub

lic H

ealth

(M

OPH

) R

e: Io

diz

ed S

alt

(2-M

ar-9

4)

Dec

ree

No

.19,

th

e Pr

od

uctio

n an

d

Sup

ply

of I

od

ized

Sa

lt fo

r H

uman

C

ons

ump

tion

(10-

No

v-99

)

No

te:N

utrie

ntfu

nctio

ncl

aim

isp

erm

itted

inT

haila

ndw

ithc

riter

iab

ased

on

Thai

RD

Iand

nut

rient

func

tion

clai

ms

tate

men

tin

Tha

imus

tco

nfo

rmt

ot

hes

tate

men

tth

atis

set

int

here

gul

atio

n.

Tab

le 1

A. Sa

lt Io

diz

atio

n in

SE

A

Page 12: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

10

Co

untr

yB

rune

iIn

do

nesi

aM

alay

sia

Sing

apo

reTh

aila

nd

Fort

ifica

ntPo

tass

ium

iod

ide,

So

diu

m io

did

eIo

din

ePo

tass

ium

iod

ate,

Po

tass

ium

iod

ide,

So

diu

m io

dat

e, S

od

ium

iod

ide

Pota

ssiu

m io

dat

e, P

ota

ssiu

m io

did

e,

Sod

ium

iod

ate,

So

diu

m io

did

eIo

din

e

Foo

d V

ehic

leFo

od

for

hum

an c

ons

ump

tion

Foo

d fo

r hu

man

co

nsum

ptio

nVa

rious

typ

es o

f fo

od

s fr

om

bre

ad t

o

liqui

d fo

od

1

Foo

d fo

r hu

man

co

nsum

ptio

nFo

od

for

hum

an c

ons

ump

tion

Min

imum

A

ccep

tab

le L

evel

1/2

RD

A (5

0 m

cg) /

sp

ecifi

ed

refe

renc

e q

uant

ity

Incr

ease

of 1

0% R

DA

as

com

par

ed

to t

he re

fere

nce

foo

dR

ang

ing

fro

m 2

0 m

cg /

100

g b

read

to

500

mcg

/ 1

00g

ext

ract

of m

eat

or

veg

etab

le

1/2

RD

A (5

0 m

cg) /

sp

ecifi

ed

refe

renc

e q

uant

ityIn

crea

se o

f 10%

Tha

i RD

I as

com

par

ed t

o t

he re

fere

nce

foo

d

Max

imum

To

lera

ble

Lev

el-

-20

0mcg

/d

ay30

0mcg

of i

od

ine/

sp

ecifi

ed

refe

renc

e q

uant

ity-

Nut

rien

t C

ont

ent

and

C

om

par

ativ

e C

laim

Per

mit

ted

Ye

sYe

sYe

s, fo

llow

CO

DE

XYe

sYe

s, fo

rmat

sim

ilar

to C

od

ex, c

riter

ia

bas

ed o

n Th

ai R

DI

Nut

rien

t Fu

ncti

on

Cla

im P

erm

itte

d-

Yes

Ess

entia

l fo

r th

e fo

rmat

ion

of t

hyro

id h

orm

one

(Co

nditi

ons

: mee

t th

e cr

iteria

fo

r “s

our

ce o

f” c

laim

)

Ess

entia

l fo

r th

e sy

nthe

sis

of t

hyro

id h

orm

one

s b

y th

e th

yro

id g

land

.(C

ond

itio

ns: m

eet

the

crite

ria

for

“pre

senc

e o

f” c

laim

(1/6

RD

A))

Uno

ffici

alt

rans

latio

n:

an in

teg

ral p

art

of t

he t

hyro

id

horm

one

s w

hich

reg

ulat

e g

row

th

and

dev

elo

pm

ent

of b

od

y an

d b

rain

fu

nctio

ns

Dis

ease

Ris

k R

educ

tio

n

Cla

im P

erm

itte

d-

No

t p

erm

itted

No

t p

erm

itted

No

t p

erm

itted

No

t p

erm

itted

Reg

ulat

ing

bo

dy

Dep

artm

ent

of H

ealth

Ser

vice

s,

Min

istr

y o

f Hea

lth

Nat

iona

l Ag

ency

for

Dru

g a

nd

Foo

d C

ont

rol

Foo

d S

afet

y an

d Q

ualit

y D

ivis

ion

- M

inis

try

of H

ealth

Mal

aysi

aA

gri-

Foo

d &

Vet

erin

ary

Aut

horit

y o

f Sin

gap

ore

Foo

d a

nd D

rug

A

dm

inis

trat

ion

Reg

ulat

ion

Nam

e/D

ate

Pub

lic H

ealth

(Fo

od

) A

ct (C

hap

ter

182)

(1-F

eb-0

1)- - Fu

nctio

nal F

oo

d 2

005

Ref

eren

ce V

alue

for

Nut

ritio

n La

bel

ing

of F

oo

d 2

007

- -

Foo

d A

ct 1

983

(Act

281

) and

R

egul

atio

ns 1

985

Gui

de

to N

utrit

ion

Lab

elin

g a

nd C

laim

s as

at

Dec

emb

er 2

007

- -

Sale

of F

oo

d A

ct (C

hap

ter

283,

Se

ctio

n 38

(1))

Foo

d R

egul

atio

ns a

nd

Foo

d (A

men

dm

ent)

R

egul

atio

ns 2

011

A G

uid

e to

Fo

od

Lab

ellin

g

and

Ad

vert

isem

ents

201

0

No

tifica

tion

of t

he M

inis

try

of P

ublic

H

ealth

No

.182

/ 2

541(

1998

), N

utrit

ion

Lab

ellin

g

1In

clud

ing

veg

etab

leju

ice,

frui

tju

ice,

frui

tju

ice

conc

entr

ate,

frui

tsy

rup

,flav

our

eds

yrup

(dilu

ted

acc

ord

ing

to

dire

ctio

ns).

No

te:N

utrie

ntfu

nctio

ncl

aim

isp

erm

itted

inT

haila

ndw

ithc

riter

iab

ased

on

Thai

RD

Iand

nut

rient

func

tion

clai

ms

tate

men

tin

Tha

imus

tco

nfo

rmt

ot

hes

tate

men

tth

atis

set

int

here

gul

atio

n.

Tab

le 1

B. R

egul

ato

ry s

tatu

s o

f cl

aim

s o

n io

din

e fo

rtifi

cati

on

in S

EA

Page 13: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

11

Co

untr

yIn

do

nesi

aTh

e P

hilip

pin

esV

ietn

am

Fort

ifica

ntE

lem

enta

l iro

nFe

rric

am

mo

nium

citr

ate,

Fer

ric p

hosp

hate

, Fer

ric p

yro

pho

spha

te,

Ferr

ic s

od

ium

pyr

op

hosp

hate

, Fer

rous

fum

arat

e, F

erro

us g

luco

nate

, Fer

rous

la

ctat

e, F

erro

us s

ulfa

te, E

lem

enta

l iro

n (e

lect

roly

tic, I

I red

uced

, p

artic

le s

ize

sho

uld

be ≤

50 m

icro

ns)

Ele

men

tal i

ron

NaF

eED

TA

Foo

d V

ehic

leW

heat

flo

ur-

All

rice,

exc

ept

bro

wn

rice

and

loca

lly p

rod

uced

glu

tino

us r

ice

- W

heat

flo

ur

Pro

cess

ed fo

od

s th

at c

ont

ain

at le

ast

40 k

iloca

lorie

s p

er

norm

al s

ervi

ng

Whe

at fl

our

Fish

sau

ce

Stat

usM

and

ato

ryM

and

ato

ryVo

lunt

ary

Volu

ntar

y

Min

imum

Acc

epta

ble

Lev

el50

mg

/kg

- 60

mg

Fe/

kg r

aw r

ice;

- 70

mg

Fe/

kg w

heat

flo

ur1/

3 R

DA

of t

arg

et c

ons

umer

(4

mg

for

adul

t; 3

.3 m

g fo

r ch

ild)

/ nu

mb

er o

f ser

ving

s lik

ely

to b

e co

nsum

ed in

a d

ay

60 m

g/k

g

300

mg

/L

Max

imum

To

lera

ble

Lev

el-

- 90

mg

Fe/

kg r

aw r

ice;

-

105

mg

Fe/

kg w

heat

flo

urN

A-

500

mg

/L

Lab

elin

g R

equi

rem

ent

SNI m

ark

Dia

mo

nd S

ang

kap

Pin

oy

Seal

fo

r St

aple

sSa

ngka

p P

ino

y Se

al fo

r Pr

oce

ssed

Fo

od

s-

Nut

rien

t C

ont

ent

and

C

om

par

ativ

e C

laim

Per

mit

ted

Ye

sYe

s, fo

llow

CO

DE

X, c

riter

ia b

ased

on

Phili

pp

ines

RE

NI

-

Nut

rien

t Fu

ncti

on

Cla

im

Per

mit

ted

Yes

Yes,

follo

w C

OD

EX

-

Dis

ease

Ris

k R

educ

tio

n C

laim

P

erm

itte

dN

ot

per

mitt

edYe

s, fo

llow

CO

DE

X-

Reg

ulat

ing

bo

dy

Min

istr

y O

f Ind

ustr

yD

epar

tmen

t o

f Hea

lth t

hro

ugh

Foo

d a

nd D

rug

Ad

min

istr

atio

n (F

DA

) Phi

lipp

ines

Min

istr

y o

f Hea

lth

Reg

ulat

ion

Nam

e/D

ate

Min

istr

y o

f Hea

lth R

egul

atio

n o

f th

e M

inis

ter

of I

ndus

try

Num

ber

42

/M-I

ND

/PE

R/

11/2

005

Year

200

5 o

n Pr

oce

ssin

g, P

acka

gin

g a

nd

Lab

elin

g o

f Io

diz

ed S

alt

(29-

No

v-05

)

- -

Rep

ublic

Act

no

897

6, P

hilip

pin

e Fo

od

Fo

rtifi

catio

n A

ct o

f 200

0 (7

-No

v-00

)B

urea

u C

ircul

ar 2

007-

002,

G

uid

elin

es in

the

Use

of N

utrit

ion

and

Hea

lth C

laim

s in

Fo

od

(2

3-Ja

n-07

)

- -

Ad

min

istr

ativ

e O

rder

No

. 4-A

s.

1995

, Gui

del

ines

on

Mic

ronu

trie

nt

Fort

ifica

tion

of P

roce

ssed

Fo

od

s (1

4-Fe

b-9

5)B

urea

u C

ircul

ar 2

007-

002,

G

uid

elin

es in

the

Use

of N

utrit

ion

and

Hea

lth C

laim

s in

Fo

od

(2

3-Ja

n-07

)

Dec

isio

n N

o 6

289/

2003

/QD

-BYT

, Tec

hnic

al R

egul

atio

n o

n

Foo

d F

ort

ifica

tion

(9-D

ec-0

3)

No

te:N

utrie

ntfu

nctio

ncl

aim

isp

erm

itted

inT

haila

ndw

ithc

riter

iab

ased

on

Thai

RD

Iand

nut

rient

func

tion

clai

ms

tate

men

tin

Tha

imus

tco

nfo

rmt

ot

hes

tate

men

tth

atis

set

int

here

gul

atio

n.

Tab

le 2

A. Ir

on

fort

ifica

tio

n p

rog

ram

s in

SE

A

Page 14: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

12

Co

untr

yB

rune

iIn

do

nesi

aM

alay

sia

Sing

apo

reTh

aila

nd

Fort

ifica

ntE

lect

roly

tic ir

on,

Fer

ric p

hosp

hate

, Fe

rric

pyr

op

hosp

hate

, Fer

rous

g

luco

nate

, Fer

rous

lact

ate,

Fer

rous

su

lpha

te,

Ele

men

tal i

ron

Iron-

case

in c

om

ple

x, C

arb

ony

l iro

n,

Ele

ctro

lytic

iro

n, F

erric

am

mo

nium

ci

trat

e, F

erric

cas

eina

te, F

erric

ci

trat

e, F

erric

glu

cona

te, F

erric

p

hosp

hate

, Fer

ric p

yro

pho

spha

te,

Ferr

ic s

acch

arat

e, F

erro

us

carb

ona

te, F

erro

us c

itrat

e, F

erro

us

fum

arat

e, F

erro

us g

luco

nate

, Fe

rro

us la

ctat

e, F

erro

us s

ucci

nate

, Fe

rro

us s

ulp

hate

, Hyd

rog

en

red

uced

iro

n, S

od

ium

ferr

ic

pyr

op

hosp

hate

Car

bo

nyl i

ron,

Ele

ctro

lytic

iro

n,

Ferr

ic a

mm

oni

um c

itrat

e, F

erric

ci

trat

e, F

erric

glu

cona

te, F

erric

p

hosp

hate

, Fer

ric p

yro

pho

spha

te,

Ferr

ic s

acch

arat

e, F

erro

us

carb

ona

te, F

erro

us c

itrat

e, F

erro

us

fum

arat

e, F

erro

us g

luco

nate

, Fe

rro

us la

ctat

e, F

erro

us s

ucci

nate

, Fe

rro

us s

ulp

hate

, Hyd

rog

en

red

uced

iro

n, S

od

ium

ferr

ic

pyr

op

hosp

hate

Iron

Foo

d V

ehic

leFo

od

for

hum

an c

ons

ump

tion

Foo

d fo

r hu

man

co

nsum

ptio

nVa

rious

typ

es o

f fo

od

s fr

om

bre

ad

to li

qui

d fo

od

1

Foo

d fo

r hu

man

co

nsum

ptio

nFo

od

for

hum

an c

ons

ump

tion

Min

imum

Acc

epta

ble

Lev

el1/

2 R

DA

(5 m

g) /

sp

ecifi

ed

refe

renc

e q

uant

ity

Incr

ease

of 1

0% R

DA

as

com

par

ed t

o t

he re

fere

nce

foo

dR

ang

ing

fro

m 2

0 m

cg /

10

0 g

bre

ad t

o 5

00 m

cg /

100

g

extr

act

of m

eat

or

veg

etab

le

1/2

RD

A (5

mg

) / s

pec

ified

re

fere

nce

qua

ntity

Incr

ease

of 1

0% T

hai R

DI a

s co

mp

ared

to

the

refe

renc

e fo

od

Max

imum

To

lera

ble

Lev

el-

-20

0 m

cg /

day

30 m

g o

f iro

n /

spec

ified

refe

renc

e q

uant

ity-

Nut

rien

t C

ont

ent

and

C

om

par

ativ

e C

laim

Per

mit

ted

Ye

sYe

sYe

s, fo

llow

CO

DE

XYe

sYe

s, fo

rmat

sim

ilar

to C

od

ex,

crite

ria b

ased

on

Thai

RD

I

Nut

rien

t Fu

ncti

on

Cla

im P

erm

itte

d-

Yes

Fact

or

in re

d b

loo

d c

ell f

orm

atio

n;

com

po

nent

of h

aem

og

lob

in in

red

b

loo

d c

ell w

hich

car

ry o

xyg

en t

o a

ll p

arts

of t

he b

od

y.

(Co

nditi

ons

: mee

t th

e cr

iteria

for

“so

urce

of”

cla

im)

An

imp

ort

ant

com

po

nent

of r

ed

blo

od

cel

ls w

hich

car

ry o

xyg

en

to a

ll p

arts

of t

he b

od

y to

hel

p

the

bo

dy’

s p

rod

uctio

n o

f ene

rgy;

ne

eded

to

pro

duc

e ha

emo

glo

bin

, th

e p

rote

in in

red

blo

od

cel

ls t

hat

carr

ies

oxy

gen

to

tis

sues

nee

ded

to

pro

duc

e m

yog

lob

in, t

he p

rote

in

that

hel

ps

sup

ply

oxy

gen

to

m

uscl

e.

(Co

nditi

ons

: mee

t th

e cr

iteria

for

“pre

senc

e o

f” c

laim

(1/6

RD

A))

Yes,

crit

eria

bas

ed o

n Th

ai R

DI a

nd

nutr

ient

func

tion

clai

m s

tate

men

t m

ust

conf

orm

to

the

sta

tem

ent

that

se

t in

the

reg

ulat

ion.

Uno

ffici

alt

rans

latio

n: a

n in

dis

pen

sab

le c

om

po

nent

of

hem

og

lob

in in

red

blo

od

cel

ls

Dis

ease

Ris

k R

educ

tio

n C

laim

Per

mit

ted

-N

ot

per

mitt

edN

ot

per

mitt

edN

ot

per

mitt

edN

ot

per

mitt

ed

Reg

ulat

ing

bo

dy

Dep

artm

ent

of H

ealth

Ser

vice

s,

Min

istr

y o

f Hea

lth

Nat

iona

l Ag

ency

for

Dru

g

and

Fo

od

Co

ntro

l Fo

od

Saf

ety

and

Qua

lity

Div

isio

n -

Min

istr

y o

f Hea

lth M

alay

sia

Ag

ri-Fo

od

& V

eter

inar

y A

utho

rity

of S

ing

apo

reFo

od

and

Dru

g

Ad

min

istr

atio

n

Reg

ulat

ion

Nam

e/D

ate

Pub

lic H

ealth

(Fo

od

) Act

(C

hap

ter

182)

(1-F

eb-0

1)- -

Func

tiona

l Fo

od

200

5R

efer

ence

Val

ue fo

r N

utrit

ion

Lab

elin

g

- -

Foo

d A

ct 1

983

(Act

281

) and

R

egul

atio

ns 1

985

Gui

de

to N

utrit

ion

Lab

elin

g a

nd

Cla

ims

as a

t D

ecem

ber

200

7

- -

Sale

of F

oo

d A

ct (C

hap

ter

283,

Se

ctio

n 38

(1))

Foo

d R

egul

atio

ns

and

Fo

od

(Am

end

men

t)

Reg

ulat

ions

201

1A

Gui

de

to F

oo

d L

abel

ling

and

A

dve

rtis

emen

ts 2

010

No

tifica

tion

of t

he M

inis

try

of

Pub

lic H

ealth

No

.182

/ 2

541(

1998

), N

utrit

ion

Lab

ellin

g

Tab

le 2

B. R

egul

ato

ry s

tatu

s o

f cl

aim

s o

n ir

on

fort

ifica

tio

n in

SE

A

1In

clud

ing

veg

etab

leju

ice,

frui

tju

ice,

frui

tju

ice

conc

entr

ate,

frui

tsy

rup

,flav

our

eds

yrup

(dilu

ted

acc

ord

ing

to

dire

ctio

ns).

Page 15: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

13

Co

untr

yTh

e P

hilip

pin

esTh

aila

ndV

ietn

am

Fort

ifica

ntR

etin

ol a

ceta

te, r

etin

ol p

alm

itate

Ret

ino

l ace

tate

, re

tino

l pal

mita

teB

eta

caro

tene

(P

rovi

tam

in A

)V

itam

in A

Vita

min

A p

alm

itate

Foo

d V

ehic

le-

Whe

at fl

our

; -

Refi

ned

sug

ar-

Co

oki

ng o

il fo

r hu

man

co

nsum

ptio

n

ex

cep

t fo

r ex

po

rt

Pro

cess

ed fo

od

s th

at c

ont

ain

at le

ast

40

kilo

calo

ries

per

no

rmal

ser

ving

- C

ond

ense

d m

ilk-

Mar

gar

ine

- S

ugar

- v

eget

able

oil

Stat

usM

and

ato

ryVo

lunt

ary

Man

dat

ory

Volu

ntar

y

Min

imum

Acc

epta

ble

Lev

el-

6.5

mg

retin

ol /

kg w

heat

flo

ur

- 1

.0 m

g/k

g re

fined

sug

ar-

12

mg

RE

/L c

oo

king

oil

1/3

RD

A o

f the

tar

get

co

nsum

er /

to

tal

num

ber

of s

ervi

ngs

likel

y to

be

cons

umed

in

a d

ay

- 3

3.0

mg

RE

/kg

co

nden

sed

milk

- 2

5 IU

/g m

arg

arin

e*-

15

mg

/kg

sug

ar-

50

IU/g

veg

etab

le o

il (1

5 m

g R

E/k

g)*

Max

imum

To

lera

ble

Lev

el-

30.

0 m

g re

tino

l /kg

whe

at fl

our

-

30.

0 m

g/k

g re

fined

sug

ar-

23

mg

RE

/L c

oo

king

oil

150%

of t

he R

DA

for

the

targ

et c

ons

umer

NA

--

30

mg

/kg

sug

ar-

100

IU/g

veg

etab

le o

il (3

0 m

g R

E/k

g)*

Lab

elin

g R

equi

rem

ent

Dia

mo

nd S

ang

kap

Pin

oy

Seal

for

Stap

les

Sang

kap

Pin

oy

Seal

fo

r Pr

oce

ssed

Fo

od

s-

-

Nut

rien

t C

ont

ent

and

Co

mp

arat

ive

Cla

im P

erm

itte

d

Yes,

follo

w C

OD

EX

, crit

eria

bas

ed o

n Ph

ilip

pin

es R

EN

IYe

s, fo

rmat

sim

ilar

to C

od

ex,

crite

ria b

ased

on

Thai

RD

I-

Nut

rien

t Fu

ncti

on

Cla

im P

erm

itte

dYe

s, fo

llow

CO

DE

XYe

s, c

riter

ia b

ased

on

Thai

RD

I and

nu

trie

nt fu

nctio

n cl

aim

sta

tem

ent

mus

t co

nfo

rm t

o t

he s

tate

men

t th

at is

set

in t

he

reg

ulat

ion.

Uno

ffici

alt

rans

latio

n: h

elp

pro

mo

te n

orm

al

gro

wth

and

dev

elo

pm

ent;

hel

p d

evel

op

vi

sio

n; s

upp

ort

the

dev

elo

pm

ent

and

m

aint

enan

ce o

f ep

ithel

ial c

ells

in m

ucus

m

emb

rane

s

-

Dis

ease

Ris

k R

educ

tio

n C

laim

Per

mit

ted

Yes,

follo

w C

OD

EX

No

t p

erm

itted

-

Reg

ulat

ing

bo

dy

Dep

artm

ent

of H

ealth

thr

oug

h Fo

od

and

Dru

g A

dm

inis

trat

ion

(FD

A) P

hilip

pin

esFo

od

and

Dru

g A

dm

inis

trat

ion

Min

istr

y o

f Hea

lth

Reg

ulat

ion

Nam

e/D

ate

- -

Rep

ublic

Act

no

897

6, P

hilip

pin

e Fo

od

Fo

rtifi

catio

n A

ct o

f 200

0 (7

-No

v-00

)B

urea

u C

ircul

ar 2

007-

002,

Gui

del

ines

in t

he

Use

of N

utrit

ion

and

Hea

lth C

laim

s in

Fo

od

(2

3-Ja

n-07

)

- -

Ad

min

istr

ativ

e O

rder

No

. 4-A

s. 1

995,

G

uid

elin

es o

n M

icro

nutr

ient

Fo

rtifi

catio

n o

f Pro

cess

ed F

oo

ds

(14-

Feb

-95)

Bur

eau

Circ

ular

200

7-00

2, G

uid

elin

es in

the

U

se o

f Nut

ritio

n an

d H

ealth

Cla

ims

in F

oo

d

(23-

Jan-

07)

- -

No

tifica

tion

of t

he M

inis

try

of P

ublic

Hea

lth

No

. 265

B.E

. 254

5 (2

002)

(1

9-D

ec-0

2) –

co

nden

sed

milk

No

tifica

tion

of t

he M

inis

try

of

Pub

lic H

ealth

(No

. 207

) B.E

. 254

3 (2

000)

(2

4-Ja

n-01

) – m

arg

arin

e

Dec

isio

n N

o 6

289/

2003

/QD

-BYT

,Te

chni

cal R

egul

atio

n o

n Fo

od

Fo

rtifi

catio

n (9

-Dec

-03)

*1

IU=

0.3

mcg

Ret

ino

lEq

uiva

lent

Tab

le 3

A. V

itam

in A

fo

rtifi

cati

on

pro

gra

ms

in S

EA

Page 16: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

14

Co

untr

yB

rune

iIn

do

nesi

aM

alay

sia

Sing

apo

reTh

aila

nd

Fort

ifica

ntV

itam

in A

, vita

min

A a

ceta

te, v

itam

in

A a

lco

hol,

vita

min

A p

alm

itate

, B

eta-

caro

tene

Vita

min

A, c

aro

teno

idR

etin

ol,

Ret

inyl

ace

tate

, R

etin

yl p

alm

itate

, Ret

inyl

p

rop

iona

te, B

eta-

caro

tene

Ret

ino

l, R

etin

yl a

ceta

te,

Ret

inyl

pal

mita

te, R

etin

yl

pro

pio

nate

, Bet

a-ca

rote

ne

Vita

min

A

Foo

d V

ehic

leFo

od

for

hum

an c

ons

ump

tion

Foo

d fo

r hu

man

co

nsum

ptio

nVa

rious

typ

es o

f fo

od

s fr

om

bre

ad t

o

liqui

d fo

od

Foo

d fo

r hu

man

co

nsum

ptio

nFo

od

for

hum

an c

ons

ump

tion

Min

imum

Acc

epta

ble

Lev

el1/

2 R

DA

(375

mcg

) /

spec

ified

refe

renc

e q

uant

ity

Incr

ease

of 1

0% R

DA

as

com

par

ed

to t

he re

fere

nce

foo

dR

ang

ing

fro

m 5

00 IU

of

Vita

min

A /

100

g b

read

to

12,0

00

IU o

f Vita

min

A /

100

g e

xtra

ct

of m

eat

or

veg

etab

le*

1/2

RD

A (3

75 m

cg) /

sp

ecifi

ed re

fere

nce

qua

ntity

In

crea

se o

f 10%

Tha

i RD

I as

com

par

ed t

o t

he re

fere

nce

foo

d

Max

imum

To

lera

ble

Lev

el-

-50

00 IU

/ d

ay*

750

mcg

of r

etin

ol a

ctiv

ity /

sp

ecifi

ed

refe

renc

e q

uant

ity-

Nut

rien

t C

ont

ent

and

C

om

par

ativ

e C

laim

Per

mit

ted

Ye

sYe

sYe

s, fo

llow

CO

DE

XYe

sYe

s, fo

rmat

sim

ilar

to C

od

ex, c

riter

ia

bas

ed o

n Th

ai R

DI

Nut

rien

t Fu

ncti

on

Cla

im P

erm

itte

d-

Yes

Aid

s in

mai

ntai

ning

the

hea

lth

of s

kin

and

muc

ous

mem

bra

ne;

esse

ntia

l fo

r th

e fu

nctio

ning

o

f the

eye

s(C

ond

itio

ns: m

eet

the

crite

ria fo

r “s

our

ce o

f” c

laim

)

Ess

entia

l fo

r th

e fu

nctio

ning

o

f the

eye

(Co

nditi

ons

: mee

t th

e cr

iteria

for

“pre

senc

e o

f” c

laim

(1/6

RD

A))

Uno

ffici

alt

rans

latio

n: H

elp

pro

mo

te

norm

al g

row

th a

nd d

evel

op

men

t;

help

dev

elo

p v

isio

n; s

upp

ort

the

d

evel

op

men

t an

d m

aint

enan

ce o

f ep

ithel

ial c

ells

in m

ucus

mem

bra

nes

Dis

ease

Ris

k R

educ

tio

n C

laim

Per

mit

ted

-N

ot

per

mitt

edN

ot

per

mitt

edN

ot

per

mitt

edN

ot

per

mitt

ed

Reg

ulat

ing

bo

dy

Dep

artm

ent

of H

ealth

Ser

vice

s,

Min

istr

y o

f Hea

lth

Nat

iona

l Ag

ency

for

Dru

g a

nd

Foo

d C

ont

rol

Foo

d S

afet

y an

d Q

ualit

y D

ivis

ion

- M

inis

try

of H

ealth

Mal

aysi

aA

gri-

Foo

d &

Vet

erin

ary

Aut

horit

y o

f Sin

gap

ore

Foo

d a

nd D

rug

Ad

min

istr

atio

n

Reg

ulat

ion

Nam

e/D

ate

Pub

lic H

ealth

(Fo

od

) A

ct (C

hap

ter

182)

(1-F

eb-0

1)- -

Func

tiona

l Fo

od

200

5R

efer

ence

Val

ue fo

r N

utrit

ion

Lab

elin

g o

f Fo

od

200

7

- -

Foo

d A

ct 1

983

(Act

281

) and

R

egul

atio

ns 1

985

Gui

de

to N

utrit

ion

Lab

elin

g a

nd

Cla

ims

as a

t D

ecem

ber

200

7

- -

Sale

of F

oo

d A

ct (C

hap

ter

283,

Se

ctio

n 38

(1))

Foo

d R

egul

atio

ns

and

Fo

od

(Am

end

men

t)

Reg

ulat

ions

201

1A

Gui

de

to F

oo

d L

abel

ling

and

A

dve

rtis

emen

ts 2

010

No

tifica

tion

of t

he M

inis

try

of

Pub

lic H

ealth

No

.182

/ 2

541(

1998

), N

utrit

ion

Lab

ellin

g

Tab

le 3

B. R

egul

ato

ry s

tatu

s o

f cl

aim

s o

n vi

tam

in A

fo

rtifi

cati

on

in S

EA

*1

IU=

0.3

mcg

Ret

ino

lEq

uiva

lent

No

te:N

utrie

ntfu

nctio

ncl

aim

isp

erm

itted

inT

haila

ndw

ithc

riter

iab

ased

on

Thai

RD

Iand

nut

rient

func

tion

clai

ms

tate

men

tin

Tha

imus

tco

nfo

rmt

ot

hes

tate

men

tth

atis

set

int

here

gul

atio

n.

Page 17: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

15

Co

untr

yIn

do

nesi

aTh

e P

hilip

pin

esTh

aila

ndV

ietn

am

Fort

ifica

nt-

Folic

aci

d-

Vita

min

B1:

Thi

amin

- V

itam

in B

2: R

ibo

flavi

n

- - - - - - -

B1:

Thi

amin

Hyd

roch

lorid

e,

Thia

min

Mo

noni

trat

eB

2: R

ibo

flavi

n, R

ibo

flavi

n-5-

pho

spha

te

(so

diu

m s

alt

of)

B3:

Nia

cin

or

nico

tinic

aci

d, N

iaci

nam

ide

or

nico

tinam

ide,

Nia

cina

mid

e as

corb

ate

B6:

Pyr

ido

xine

Hyd

roch

lorid

eB

7: B

iotin

B12

: Cya

noco

bal

amin

Oth

er B

Vita

min

s : F

olic

aci

d, P

anto

then

ic

acid

(cal

cium

sal

t o

f), p

anth

eno

l

- B

1: T

hiam

in

- B

2: R

ibo

flavi

n-

B3:

Nic

otin

ic a

cid

, Nic

otin

amid

e

- Fo

lic a

cid

- V

itam

in B

1: T

hiam

in-

Vita

min

B2:

Rib

ofla

vin

Foo

d V

ehic

leW

heat

flo

urPr

oce

ssed

foo

ds

that

co

ntai

n at

leas

t

40 k

iloca

lorie

s p

er n

orm

al s

ervi

ngV

itam

iniz

ed r

ice

Whe

at fl

our

Stat

usM

and

ato

ryVo

lunt

ary

Man

dat

ory

Volu

ntar

y

Min

imum

Acc

epta

ble

Lev

el-

2 m

g fo

lic a

cid

/kg

-

2.5

mg

vita

min

B1

/kg

- 4

mg

vita

min

B2

/kg

- -

Vita

min

B1,

B2,

Oth

er B

Vita

min

s :

1/3

RD

A o

f the

tar

get

co

nsum

erV

itam

in B

3, B

6, B

7, B

12: 1

/5 R

DA

of t

he

targ

et c

ons

umer

- 4

mg

vita

min

B1

/kg

- 3

mg

vita

min

B2

/kg

- 37

mg

vita

min

B3

/kg

- 2

mg

folic

aci

d /

kg

- 2.

5 m

g v

itam

in B

1 /k

g-

4 m

g v

itam

in B

2 /k

g

Max

imum

To

lera

ble

Lev

el-

NA

--

Lab

elin

g R

equi

rem

ent

SNI m

ark

--

-

Nut

rien

t C

ont

ent

and

Co

mp

arat

ive

Cla

im P

erm

itte

d

Yes

Yes,

follo

w C

OD

EX

, crit

eria

bas

ed o

n Ph

ilip

pin

es R

EN

IYe

s, fo

rmat

sim

ilar

to C

od

ex,

crite

ria b

ased

on

Thai

RD

I-

Nut

rien

t Fu

ncti

on

Cla

im P

erm

itte

dN

o fo

r fo

lic a

cid

Yes

for

Vita

min

B1

and

B2

Yes,

follo

w C

OD

EX

Yes,

crit

eria

bas

ed o

n Th

ai R

DI a

nd n

utrie

nt

func

tion

clai

m s

tate

men

t m

ust

conf

orm

to

th

e st

atem

ent

that

set

in t

he re

gul

atio

n.

Uno

ffici

alt

rans

latio

n:V

itam

in B

1: h

elp

s in

car

bo

hyd

rate

m

etab

olis

m; p

artly

hel

ps

in fu

nctio

n o

f ne

rvo

us a

nd m

uscu

lar

syst

emV

itam

in B

2: h

elp

s in

the

met

abo

lism

of

carb

ohy

dra

tes,

pro

tein

s an

d fa

tsN

iaci

n: h

elp

mai

ntai

n th

e co

nditi

on

of

muc

ous

in t

he d

iges

tive

syst

em a

nd k

eep

sk

in h

ealth

y; h

elp

s in

the

met

abo

lism

of

carb

ohy

dra

tes,

pro

tein

s an

d fa

ts.

Min

istr

y o

f Hea

lth

Dis

ease

Ris

k R

educ

tio

n C

laim

Per

mit

ted

Yes

for

folic

aci

dN

o fo

r V

itam

in B

1 an

d B

2Ye

s, fo

llow

CO

DE

XN

ot

per

mitt

ed

Reg

ulat

ing

bo

dy

- M

inis

try

Of I

ndus

try

- M

inis

try

of H

ealth

Dep

artm

ent

of H

ealth

thr

oug

h Fo

od

and

D

rug

Ad

min

istr

atio

n (F

DA

) Phi

lipp

ines

Foo

d a

nd D

rug

Ad

min

istr

atio

n

Reg

ulat

ion

Nam

e/D

ate

- -

Min

iste

r o

f Ind

ustr

y D

ecre

e N

o. 4

9/M

-IN

D/

PER

/7/2

008,

Man

dat

ory

Enf

orc

emen

t o

f W

heat

Flo

ur a

s Fo

od

(1

4-Ju

l-08)

Min

iste

r o

f Hea

lth D

ecre

e N

o 1

452/

ME

NK

ES/

SK/X

/200

3, W

heat

Flo

ur

Fort

ifica

tion

(7-O

ct-0

3)

- -

Ad

min

istr

ativ

e O

rder

No

. 4-A

s. 1

995,

G

uid

elin

es o

n M

icro

nutr

ient

Fo

rtifi

catio

n o

f Pro

cess

ed F

oo

ds

(14-

Feb

-95)

Bur

eau

Circ

ular

200

7-00

2, G

uid

elin

es in

th

e U

se o

f Nut

ritio

n an

d H

ealth

Cla

ims

in

Foo

d (

23-J

an-0

7)

No

tifica

tion

of M

inis

try

of P

ublic

Hea

lth

(MO

PH) N

o.1

50 (1

993)

D

ecis

ion

No

628

9/20

03/Q

D-B

YT,

Tech

nica

l Reg

ulat

ion

on

Foo

d F

ort

ifica

tion

(9-D

ec-0

3)

Tab

le 4

A. Fo

lic a

cid

and

B v

itam

ins

fort

ifica

tio

n p

rog

ram

s in

SE

A

Page 18: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

16

Nut

rien

tV

itam

in B

1V

itam

in B

2V

itam

in B

3V

itam

in B

5V

itam

in B

6V

itam

in B

7V

itam

in B

12

Fola

te

Fort

ifica

ntTh

iam

ine

chlo

ride

hyd

roch

lorid

e, t

hiam

ine

hyd

roch

lorid

e, t

hiam

ine

mo

noni

trat

e

Rib

ofla

vin,

rib

ofla

vin-

5-p

hosp

hate

, rib

ofla

vin-

5-p

hosp

hate

so

diu

m

Nia

cin,

nia

cina

mid

e,

nico

tinic

aci

d,

nico

tinam

ide

Cal

cium

pan

toth

enat

e,

d-p

anto

then

ic a

cid

, d

-pan

toth

enyl

alc

oho

l, p

anth

eno

l

Pyrid

oxa

l, p

yrid

oxa

min

, p

yrid

oxi

ne, p

yrid

oxi

ne

hyd

roch

lorid

e

d-b

iotin

Cya

noco

bal

amin

, hy

dro

xyco

bal

amin

Fola

cin,

folic

aci

d

Min

imum

A

ccep

tab

le L

evel

Ran

gin

g fr

om

0.

21 -

5.0

0 m

g /

100

g d

epen

din

g o

n fo

od

typ

e*

Ran

gin

g fr

om

0.

33 -

8.0

0 m

g /

10

0 g

dep

end

ing

on

foo

d t

ype*

Ran

gin

g fr

om

2.

3 -

55.0

0 m

g /

10

0 g

dep

end

ing

on

foo

d t

ype*

Ran

gin

g fr

om

1.46

- 3

5.00

mg

/

100

g d

epen

din

g o

n fo

od

typ

e*

Ran

gin

g fr

om

0.

42 -

10.

00 m

g /

10

0 g

dep

end

ing

on

foo

d t

ype*

Ran

gin

g fr

om

40

-10

00 m

cg/

100

g d

epen

din

g o

n fo

od

typ

e*

Ran

gin

g fr

om

0.

3 -

2.4

mcg

/10

0 g

dep

end

ing

on

foo

d t

ype*

Ran

gin

g fr

om

8

- 64

mcg

/

100

g d

epen

din

g o

n fo

od

typ

e*

Max

imum

To

lera

ble

Lev

el2.

2 m

g /

day

3.2

mg

/ d

ay22

mg

/ d

ay14

mg

/ d

ay40

0 m

cg /

day

400

mcg

/ d

ay40

0 m

cg /

day

400m

cg /

day

Nut

rien

t Fu

ncti

on

Cla

im P

erm

itte

d(C

ond

itio

ns: m

eet

the

crite

ria fo

r “s

our

ce o

f” c

laim

)

Nee

ded

for

the

rele

ase

of e

nerg

y fr

om

ca

rbo

hyd

rate

Nee

ded

for

the

rele

ase

of e

nerg

y fr

om

pro

tein

s,

fats

and

car

bo

hyd

rate

s

Nee

ded

for

the

rele

ase

of e

nerg

y fr

om

pro

tein

s,

fats

and

car

bo

hyd

rate

s

--

-N

eed

ed fo

r re

d b

loo

d

cell

pro

duc

tion

Folic

aci

d is

ess

entia

l fo

r g

row

th a

nd

div

isio

n o

f cel

ls;

Fola

te p

lays

a ro

le

in a

form

atio

n o

f re

d b

loo

d c

ells

and

he

lps

to m

aint

ain

the

gro

wth

and

d

evel

op

men

t o

f the

fo

etus

*C

laim

on

fort

ifica

tion

isa

llow

edo

nva

rious

typ

eso

ffo

od

sfr

om

bre

adt

oli

qui

dfo

od

.

No

te:N

utrie

ntc

ont

enta

ndc

om

par

ativ

ecl

aim

are

per

mitt

ed,f

ollo

win

gC

od

ex.D

isea

seri

skre

duc

tion

clai

mis

no

tper

mitt

ed.T

hec

laim

on

Bv

itam

ins

fort

ifica

tion

isre

gul

ated

by

Foo

dA

ct1

983

(Act

281

)and

Reg

ulat

ions

198

5&

Gui

de

toN

utrit

ion

Lab

elin

ga

nd

Cla

ims

asa

tD

ecem

ber

200

7un

der

the

Fo

od

Saf

ety

and

Qua

lity

Div

isio

n,M

inis

try

ofH

ealth

,Mal

aysi

a.

Tab

le 4

B. R

egul

ato

ry s

tatu

s o

f cl

aim

s o

n fo

late

and

B v

itam

ins

fort

ifica

tio

n in

Mal

aysi

a

Page 19: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

17

Nut

rien

tV

itam

in B

1V

itam

in B

2V

itam

in B

3V

itam

in B

6V

itam

in B

12

Fola

te

Fort

ifica

ntTh

iam

in, a

neur

ine,

thi

amin

hy

dro

chlo

ride,

thi

amin

m

ono

nitr

ate

Rib

ofla

vin,

rib

ofla

vin-

5-p

hosp

hate

so

diu

mN

iaci

n, n

iaci

nam

ide,

ni

cotin

ic a

cid

, nic

otin

amid

ePy

rido

xal,

pyr

ido

xam

in,

pyr

ido

xine

, pyr

ido

xine

hy

dro

chlo

ride

Co

bal

amin

, cya

noco

bal

amin

, hy

dro

xyco

bal

amin

Folic

aci

d

Min

imum

A

ccep

tab

le L

evel

1/2

RD

A (0

.5 m

g) /

sp

ecifi

ed

refe

renc

e q

uant

ity1/

2 R

DA

(0.7

5 m

g) /

sp

ecifi

ed

refe

renc

e q

uant

ity1/

2 R

DA

(8 m

g) /

sp

ecifi

ed

refe

renc

e q

uant

ity1/

2 R

DA

(1 m

g) /

sp

ecifi

ed

refe

renc

e q

uant

ity1/

2 R

DA

(1 m

cg) /

sp

ecifi

ed

refe

renc

e q

uant

ity1/

2 R

DA

(100

mcg

) / s

pec

ified

re

fere

nce

qua

ntity

Nut

rien

t Fu

ncti

on

Cla

im

Per

mit

ted

(Co

nditi

ons

: mee

t th

e cr

iteria

fo

r “s

our

ce o

f” c

laim

)

Hel

ps

to re

leas

e en

erg

y fr

om

pro

tein

s, fa

ts a

nd

carb

ohy

dra

tes.

Hel

ps

to re

leas

e en

erg

y fr

om

pro

tein

s, fa

ts a

nd

carb

ohy

dra

tes

Hel

ps

to re

leas

e en

erg

y fr

om

pro

tein

s, fa

ts a

nd

carb

ohy

dra

tes

Imp

ort

ant

for

the

pro

duc

tion

of e

nerg

yN

eces

sary

for

fat,

ca

rbo

hyd

rate

and

pro

tein

m

etab

olis

m; n

eed

ed fo

r/he

lps

in t

he fo

rmat

ion

of r

edb

loo

d c

ells

For

pre

gna

nt w

om

en:

help

s su

pp

ort

foet

us’ g

row

th

and

ove

rall

dev

elo

pm

ent;

pla

ys a

role

in t

he fo

rmat

ion

of

red

blo

od

cel

ls;

take

n b

efo

re a

nd d

urin

g

early

pre

gna

ncy,

hel

ps

in t

he

men

tal/

norm

al a

nd o

vera

ll d

evel

op

men

t o

f fo

etus

; es

sent

ial/

imp

ort

ant

for

gro

wth

an

d d

ivis

ion

of c

ells

No

te:C

laim

on

fort

ifica

tion

isa

llow

edo

nfo

od

for

hum

anc

ons

ump

tion.

Sin

gap

ore

do

esn

ot

set

max

imum

allo

wab

leli

mit.

Nut

rient

co

nten

tan

dc

om

par

ativ

ecl

aim

are

per

mitt

ed.D

isea

ser

isk

red

uctio

ncl

aim

isn

ot

per

mitt

ed.T

hec

laim

on

fort

ifica

tion

by

Ag

ri-Fo

od

&V

eter

inar

yA

utho

rity

ofS

ing

apo

reis

as

stip

ulat

edu

nder

the

Sal

eo

fFo

od

Act

(Cha

pte

r28

3,S

ectio

n38

(1))

Foo

dR

egul

atio

nsa

ndF

oo

d(A

men

dm

ent)

Reg

ulat

ions

201

1an

dt

heG

uid

eto

Fo

od

Lab

ellin

ga

ndA

dve

rtis

emen

ts2

010

Tab

le 4

C. R

egul

ato

ry s

tatu

s o

f cl

aim

s o

n fo

late

and

B v

itam

ins

fort

ifica

tio

n in

Sin

gap

ore

Page 20: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

18

Nut

rien

tV

itam

in B

1V

itam

in B

2V

itam

in B

3V

itam

in B

5V

itam

in B

6V

itam

in B

7V

itam

in B

12

Fola

te

Fort

ifica

ntTh

iam

ine,

thi

amin

ehy

dro

chlo

ride,

thia

min

e m

ono

nitr

ate

Rib

ofla

vin,

rib

ofla

vin-

5-p

hosp

hate

Nia

cin,

nia

cina

mid

e,

nico

tinic

aci

d,

nico

tinam

ide

Cal

cium

pan

toth

enat

e,

sod

ium

pan

toth

enat

e,

d-p

anto

then

ic a

cid

, d

-pan

toth

enyl

alc

oho

l,

Pyrid

oxa

l, p

yrid

oxa

min

, p

yrid

oxi

ne, p

yrid

oxi

ne

hyd

roch

lorid

e

Bio

tinV

itam

in B

12Fo

lic a

cid

Min

imum

A

ccep

tab

le L

evel

(B

rune

i)

1/2

RD

A (0

.5 m

g) /

sp

ecifi

ed re

fere

nce

qua

ntity

1/2

RD

A (0

.75

mg

) /

spec

ified

refe

renc

e q

uant

ity

1/2

RD

A (8

mg

) /

spec

ified

refe

renc

e q

uant

ity

1/2

RD

A (3

.5 m

g) /

sp

ecifi

ed re

fere

nce

qua

ntity

1/2

RD

A (1

mg

) /

spec

ified

refe

renc

e q

uant

ity

1/2

RD

A (1

00 m

cg) /

sp

ecifi

ed re

fere

nce

qua

ntity

1/2

RD

A (1

.5 m

cg) /

sp

ecifi

ed re

fere

nce

qua

ntity

1/2

RD

A (0

.2 m

g) /

sp

ecifi

ed re

fere

nce

qua

ntity

Min

imum

A

ccep

tab

le L

evel

(In

do

nesi

a /

Thai

land

)

Incr

ease

d o

f 10%

RD

A o

r Th

ai R

DI a

s co

mp

ared

to

the

refe

renc

e fo

od

Nut

rien

t Fu

ncti

on

Cla

im P

erm

itte

d

(Ind

one

sia)

Yes

Yes

Yes

No

Yes

No

Yes

No

Nut

rien

t Fu

ncti

on

Cla

im P

erm

itte

d

(Tha

iland

) –

Uno

ffici

al tr

ansl

atio

n

Hel

ps

in c

arb

ohy

dra

te

met

abo

lism

; par

tly

help

s in

func

tion

of

nerv

ous

and

mus

cula

r sy

stem

Hel

ps

in t

he m

etab

olis

m

of c

arb

ohy

dra

tes,

p

rote

ins

and

fats

Hel

p m

aint

ain

the

cond

itio

n o

f muc

ous

in

the

dig

estiv

e sy

stem

an

d k

eep

ski

n he

alth

y;

help

s in

the

met

abo

lism

o

f car

bo

hyd

rate

s,

pro

tein

s an

d fa

ts

Hel

p in

util

izin

g

(met

abo

lism

of)

fat

and

car

bo

hyd

rate

; he

lp in

util

izin

g fa

t an

d

carb

ohy

dra

te; h

elp

in

met

abo

lism

of f

at a

nd

carb

ohy

dra

te

Pro

mo

tes

red

blo

od

ce

lls fo

rmat

ion;

hel

ps

in p

rod

ucin

g n

eces

sary

m

etab

olit

e fo

r m

aint

aini

ng t

he n

orm

al

nerv

e fu

nctio

n

Imp

ort

ant

com

po

nent

in

utili

zing

(met

abo

lism

of)

fat

and

car

bo

hyd

rate

; Im

po

rtan

t co

mp

one

nt

in u

tiliz

ing

fat

and

ca

rbo

hyd

rate

; Im

po

rtan

t co

mp

one

nt in

m

etab

olis

m o

f fat

and

ca

rbo

hyd

rate

Hel

p in

syn

thes

is o

f es

sent

ial s

ubst

ance

s fo

r fo

rmat

ion

of r

ed b

loo

d

cells

; hel

p p

rom

ote

fu

nctio

n o

f the

ner

vous

an

d b

rain

sys

tem

.

Nec

essa

ry fo

r th

e fo

rmat

ion

of r

ed b

loo

d

cells

; nec

essa

ry

for

reg

ulat

ing

em

bry

oni

c ne

ural

tu

be

and

ner

ve c

ell

form

atio

n in

ear

ly

pre

gna

ncy.

No

te:C

laim

on

fort

ifica

tion

inB

rune

i,In

do

nesi

a,a

ndT

haila

ndis

allo

wed

on

foo

dfo

rhu

man

co

nsum

ptio

n.B

rune

i,In

do

nesi

a,a

ndT

haila

ndd

on

ot

set

max

imum

allo

wab

leli

mit.

Nut

rient

func

tion

clai

ma

ndd

isea

sere

duc

tion

clai

ma

ren

ot

per

mitt

edin

Bru

nei.

Nut

rient

co

nten

tand

co

mp

arat

ive

clai

ms

are

per

mitt

edin

Ind

one

sia

fora

llth

eab

ove

mic

ronu

trie

nts

exce

ptv

itam

inB

7.E

xcep

tfo

rfo

lica

cid

,dis

ease

red

uctio

ncl

aim

isn

otp

erm

itted

inIn

do

nesi

a.N

utrie

ntc

ont

ent,

co

mp

arat

ive,

and

func

tion

clai

ms

are

per

mitt

ed

inT

haila

ndfo

ral

lthe

ab

ove

mic

ronu

trie

nts,

with

crit

eria

bas

edo

nTh

aiR

DI;

nutr

ient

func

tion

clai

ms

tate

men

tm

ust

com

form

to

the

sta

tem

ent

that

iss

etin

the

reg

ulat

ion.

Dis

ease

ris

kre

duc

tion

clai

mis

no

tp

erm

itted

inT

haila

nd.

Pro

visi

on

on

fort

ifica

tio

ncl

aim

inB

rune

iis

mad

ein

Pub

licH

ealt

h(F

oo

d)

Act

(C

hap

ter

182)

und

erD

epar

tmen

to

fH

ealt

hSe

rvic

es,

Min

istr

yo

fH

ealt

h.P

rovi

sio

no

nfo

rtifi

cati

on

clai

min

Ind

one

sia

ism

ade

inF

unct

iona

lFo

od

200

5wit

hR

DA

sta

ted

in

Ref

eren

ceV

alue

fo

rN

utri

tio

nLa

bel

ing

of

Foo

d2

007

und

erN

atio

nal

Ag

ency

fo

rD

rug

and

Fo

od

Co

ntro

l.P

rovi

sio

no

nfo

rtifi

cati

on

clai

mi

nT

haila

ndi

sm

ade

inN

oti

ficat

ion

of

the

Min

istr

yo

fP

ublic

Hea

lth

No

.182

/2

541(

1998

),N

utri

tio

nLa

bel

ling

un

der

Fo

od

and

Dru

gA

dm

inis

trat

ion.

Tab

le 4

D. R

egul

ato

ry s

tatu

s o

f cl

aim

s o

n fo

late

and

B v

itam

ins

fort

ifica

tio

n in

Bru

nei,

Ind

one

sia,

and

Tha

iland

Page 21: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

19

Co

untr

yIn

do

nesi

aTh

e P

hilip

pin

esV

ietn

amTh

aila

nd

Fort

ifica

ntZi

ncZi

nc c

hlo

ride,

Zin

c g

luco

nate

, Zi

nc o

xid

e, Z

inc

stea

rate

, Zi

nc s

ulfa

te

Zinc

Zinc

Foo

d V

ehic

leW

heat

flo

urFo

od

for

hum

an c

ons

ump

tion

Pro

cess

ed fo

od

s th

at c

ont

ain

at

leas

t 40

kilo

calo

ries

per

no

rmal

se

rvin

g

Whe

at F

lour

Foo

d fo

r hu

man

co

nsum

ptio

n

Stat

usM

and

ato

ryFo

r fo

rtifi

catio

n cl

aim

Volu

ntar

yVo

lunt

ary

For

fort

ifica

tion

clai

m

Min

imum

Acc

epta

ble

Lev

el30

mg

/kg

In

crea

se o

f 10%

RD

A a

s co

mp

ared

to

the

refe

renc

e fo

od

1/5

RD

A o

f the

tar

get

co

nsum

er30

mg

/kg

In

crea

se o

f 10%

Tha

i RD

I as

com

par

ed t

o t

he re

fere

nce

foo

d

Max

imum

To

lera

ble

Lev

el-

-15

0% o

f the

RD

A fo

r th

e ta

rget

co

nsum

er-

-

Lab

elin

g R

equi

rem

ent

SNI m

ark

--

--

Nut

rien

t C

ont

ent

and

C

om

par

ativ

e C

laim

Per

mit

ted

Ye

sYe

sYe

s, fo

llow

CO

DE

X, c

riter

ia b

ased

o

n Ph

ilip

pin

es R

EN

I-

Yes

Nut

rien

t Fu

ncti

on

Cla

im P

erm

itte

dN

oN

oYe

s, fo

llow

CO

DE

X-

Uno

ffici

alt

rans

latio

n:

pro

mo

te n

orm

al g

row

th

Dis

ease

Ris

k R

educ

tio

n C

laim

P

erm

itte

dN

oN

oYe

s, fo

llow

CO

DE

X-

No

Reg

ulat

ing

bo

dy

- M

inis

try

of I

ndus

try

- M

inis

try

of H

ealth

Nat

iona

l Ag

ency

for

Dru

g a

nd

Foo

d C

ont

rol

Dep

artm

ent

of H

ealth

thr

oug

h Fo

od

an

d D

rug

Ad

min

istr

atio

n (F

DA

) Ph

ilip

pin

es

Min

istr

y o

f Hea

lthFo

od

and

Dru

g A

dm

inis

trat

ion

Reg

ulat

ion

Nam

e/D

ate

- - -

Min

istr

y o

f Ind

ustr

y D

ecre

e N

o.

49/M

-IN

D/P

ER

/7/2

008,

Man

dat

ory

E

nfo

rcem

ent

of W

heat

Flo

ur a

s Fo

od

(14-

Jul-0

8)

Min

istr

y o

f Hea

lth D

ecre

e N

o 1

452/

ME

NK

ES/

SK/X

/ 20

03,

Whe

at F

lour

Fo

rtifi

catio

n (7

-Oct

-03)

Func

tiona

l Fo

od

200

5

- -Fo

od

Lab

elin

g G

uid

e 20

04R

efer

ence

Val

ue fo

r N

utrit

ion

Lab

elin

g o

f Fo

od

200

7

- -

Ad

min

istr

ativ

e O

rder

No

. 4-A

s.

1995

, Gui

del

ines

on

Mic

ronu

trie

nt

Fort

ifica

tion

of P

roce

ssed

Fo

od

s (1

4-Fe

b-9

5)B

urea

u C

ircul

ar 2

007-

002,

G

uid

elin

es in

the

Use

of N

utrit

ion

and

Hea

lth C

laim

s in

Fo

od

(2

3-Ja

n-07

)

Dec

isio

n N

o 6

289/

2003

/QD

-BYT

, Te

chni

cal R

egul

atio

n o

n Fo

od

Fo

rtifi

catio

n (9

-Dec

-03)

No

tifica

tion

of t

he M

inis

try

of

Pub

lic H

ealth

No

.182

/ 2

541(

1998

), N

utrit

ion

Lab

ellin

g

Tab

le 5

. Z

inc

fort

ifica

tio

n p

rog

ram

s an

d r

egul

ato

ry s

tatu

s o

f cl

aim

s o

n zi

nc f

ort

ifica

tio

n in

SE

A r

egio

n

No

te:N

utrie

ntfu

nctio

ncl

aim

isp

erm

itted

inT

haila

ndw

ithc

riter

iab

ased

on

Thai

RD

Iand

nut

rient

func

tion

clai

ms

tate

men

tin

Tha

imus

tco

nfo

rmt

ot

hes

tate

men

tth

atis

set

int

here

gul

atio

n

Page 22: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

20

Nut

rien

tV

itam

in C

Vit

amin

DV

itam

in E

Vit

amin

KC

alci

umC

op

per

Mag

nesi

umM

ang

anes

eSe

leni

um

Fort

ifica

ntA

sco

rbic

aci

d

(cal

cium

/ so

diu

m

salt

of)

- -Vita

min

D2:

E

rgo

calc

ifero

lV

itam

in D

3:

Cho

le c

alci

fero

l

DL-

alp

ha-

toco

phe

rol,

D-a

lpha

-to

cop

hero

l, D

L-al

pha

-toc

ophe

ryl

acet

ate,

D-a

lpha

-to

cop

hery

l ace

tate

, To

cop

hero

ls, m

ixed

co

ncen

trat

e

Phyt

ona

dio

neC

alci

um

(no

n-ca

lcin

ated

or

calc

inat

ed),

Cal

cium

ca

rbo

nate

, Cal

cium

ch

lorid

e, C

alci

um

citr

ate,

Cal

cium

la

ctat

e, C

alci

um

oxi

de,

Cal

cium

p

hosp

hate

(mo

no, d

i-, a

nd

tri-b

asic

, gly

cero

-,

pyr

o-)

Co

pp

er G

luco

nate

, C

op

per

Sul

fate

Mag

nesi

um

carb

ona

te,

Mag

nesi

um c

hlo

ride,

M

agne

sium

lact

ate,

M

agne

sium

oxi

de,

M

agne

sium

p

hosp

hate

(d

i- an

d t

ribas

ic),

Mag

nesi

um s

ulfa

te

Man

gan

ese

chlo

ride,

M

ang

anes

e ci

trat

e,

Man

gan

ese

glu

cona

te,

Man

gan

ese

gly

cero

pho

spha

te,

Man

gan

ese

sulfa

te

Sod

ium

sel

enat

e

Min

imum

A

ccep

tab

le L

evel

1/3

RD

A o

f the

ta

rget

co

nsum

er,

exce

pt

for

fort

ified

ju

ices

/flav

ore

d

drin

ks t

o p

rovi

de

at

leas

t 10

0% R

DA

1/5

RD

A o

f the

ta

rget

co

nsum

er1/

5 R

DA

of t

he

targ

et c

ons

umer

1/5

RD

A o

f the

ta

rget

co

nsum

er1/

3 R

DA

of t

he

targ

et c

ons

umer

1/5

safe

and

ad

equa

te d

aily

in

take

1/5

RD

A o

f the

ta

rget

co

nsum

er1/

5 sa

fe a

nd

adeq

uate

dai

ly

inta

ke

1/5

RD

A o

f the

ta

rget

co

nsum

er

Max

imum

To

lera

ble

Le

vel

NA

150%

of t

he R

DA

for

the

targ

et c

ons

umer

150%

of t

he R

DA

for

the

targ

et c

ons

umer

150%

of t

he R

DA

for

the

targ

et c

ons

umer

NA

NA

NA

NA

150%

of t

he R

DA

for

the

targ

et c

ons

umer

No

te:V

olu

ntar

yfo

rtifi

catio

np

rog

ram

ap

plie

sto

pro

cess

edfo

od

sth

atc

ont

ain

atle

ast

40k

iloca

lorie

sp

ern

orm

als

ervi

ng.N

utrie

ntc

ont

ent

and

co

mp

arat

ive

clai

ma

rep

erm

itted

,fo

llow

ing

Co

dex

with

crit

eria

bas

edo

nPh

ilip

pin

esR

EN

I;N

utrit

ion

func

tion

clai

m

and

dis

ease

risk

red

uctio

ncl

aim

isp

erm

itted

,fo

llow

ing

Co

dex

;The

fort

ifica

tion

isre

gul

ated

by

Ad

min

istr

ativ

eO

rder

No

.4-A

s.1

995

“Gui

del

ines

on

Mic

ronu

trie

ntF

ort

ifica

tion

ofP

roce

ssed

Fo

od

s”&

Bur

eau

Circ

ular

200

7-00

2“G

uid

elin

esin

the

Use

ofN

utrit

ion

and

Hea

lthC

laim

sin

Fo

od

”un

der

Dep

artm

ent

ofH

ealth

thr

oug

hFo

od

and

Dru

gA

dm

inis

trat

ion

(FD

A)P

hilip

pin

es.

Tab

le 6

A. V

olu

ntar

y fo

rtifi

cati

on

pro

gra

ms

wit

h o

ther

vit

amin

s an

d m

iner

als

in t

he P

hilip

pin

es

Page 23: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

21

Nut

rien

tV

itam

in C

Vit

amin

DV

itam

in E

Cal

cium

Pho

spho

rus

Fort

ifica

ntA

sco

rbic

aci

d, A

sco

rbyl

pal

mita

te,

Sod

ium

asc

orb

ate

vita

min

D2,

D3

Toco

phe

rols

, alp

ha-t

oco

phe

rol

acet

ate

Cal

cium

car

bo

nate

, Cal

cium

citr

ate,

C

alci

um g

lyce

rop

hosp

hate

, Cal

cium

o

xid

e, C

alci

um p

hosp

hate

mo

no-,

d

i, tr

i-bas

ic, C

alci

um p

yro

pho

spha

te,

Cal

cium

sul

pha

te

Cal

cium

pho

spha

te (m

ono

-, d

i-,

tri-b

asic

), So

diu

m p

hosp

hate

(mo

no-

, tri-

bas

ic)

Min

imum

acc

epta

ble

leve

l(p

er s

pec

ified

ref

eren

ce q

uant

ity)

1/2

RD

A (1

5 m

g)

1/2

RD

A (1

.25

mcg

cho

leca

lcife

rol)

1/2

RD

A (1

.75

mg

a-t

oco

phe

rol)

1/2

RD

A (2

50 m

g)

1/2

RD

A (4

00 m

g)

Tab

le 6

B. R

egul

ato

ry s

tatu

s o

f cl

aim

s o

n o

ther

vit

amin

s an

d m

iner

als

fort

ifica

tio

n in

Bru

nei D

arus

sala

m

Page 24: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

22

Nut

rien

tV

itam

in C

Vit

amin

DV

itam

in E

Po

tass

ium

Cal

cium

Mag

nesi

umM

ang

anes

eSe

leni

um

Nut

rien

t C

ont

ent

and

C

om

par

ativ

e C

laim

P

erm

itte

d

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Nut

rien

t Fu

ncti

on

Cla

im P

erm

itte

dYe

sN

oYe

sN

oYe

sN

oN

oN

o

Dis

ease

Ris

k R

educ

tio

n C

laim

P

erm

itte

d

No

No

No

Yes

Yes

No

No

No

No

te:C

laim

on

fort

ifica

tion

inIn

do

nesi

ais

allo

wed

on

foo

dfo

rhu

man

co

nsum

ptio

n.M

inim

uma

ccep

tab

leli

mit

off

ort

ifica

tion

toq

ualif

yfo

rfo

rtifi

catio

ncl

aim

isa

nin

crea

seo

f10%

RD

Aa

sco

mp

ared

to

the

ref

eren

cefo

od

.No

max

imum

allo

wab

leli

mit

iss

et.

Pro

visi

on

on

fort

ifica

tion

clai

min

Ind

one

sia

ism

ade

inF

unct

iona

lFo

od

200

5w

ithR

DA

sta

ted

inR

efer

ence

Val

uefo

rN

utrit

ion

Lab

elin

go

fFo

od

200

7un

der

Nat

iona

lAg

ency

for

Dru

ga

ndF

oo

dC

ont

rol.

Tab

le 6

C. R

egul

ato

ry s

tatu

s o

f cl

aim

s o

n o

ther

vit

amin

s an

d m

iner

als

fort

ifica

tio

n in

Ind

one

sia

Page 25: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

23

Nut

rien

tV

itam

in C

Vit

amin

DV

itam

in E

Cal

cium

Pho

spho

rus

Fort

ifica

ntA

sco

rbic

aci

d, S

od

ium

asc

orb

ate,

C

alci

um a

sco

rbat

e, S

od

ium

as

corb

ate,

Asc

orb

yl-6

-pal

mita

te

Cho

leca

lcife

rol-c

hole

ster

ol,

Vita

min

D2,

Vita

min

D3

D-a

lpha

-to

cop

hero

l,

DL-

alp

ha-t

oco

phe

rol,

D

-alp

ha-t

oco

phe

rol a

ceta

te,

DL-

alp

ha-t

oco

phe

rol a

ceta

te,

D-a

lpha

-to

cop

hery

l suc

cina

te,

DL-

alp

ha-t

oco

phe

ryl s

ucci

nate

, to

cop

hero

l

Cal

cium

car

bo

nate

, Cal

cium

ch

lorid

e, C

alci

um c

itrat

e,

Cal

cium

glu

cona

te, C

alci

um

gly

cero

pho

spha

te, C

alci

um la

ctat

e,

Cal

cium

oxi

de,

Cal

cium

pho

spha

te

mo

no-,

di,

tri-b

asic

, Cal

cium

p

yro

pho

spha

te, C

alci

um s

ulp

hate

Cal

cium

pho

spha

te

(mo

no-,

di-,

tri-

bas

ic),

Mag

nesi

um

pho

spha

te (d

i-, t

ri-b

asic

), Po

tass

ium

p

hosp

hate

(mo

no-,

d

i-bas

ic),

Sod

ium

pho

spha

te

di-b

asic

Min

imum

Acc

epta

ble

Lev

elR

ang

ing

fro

m 6

- 1

50 m

g o

f as

corb

ic a

cid

/ 1

00 g

dep

end

ing

on

foo

d t

ype*

Ran

gin

g fr

om

83

- 20

00 IU

of

vita

min

D /

100

g d

epen

din

g o

n fo

od

typ

e*†

Ran

gin

g fr

om

4.2

- 1

00.0

0 IU

of

Vita

min

E /

100

g d

epen

din

g o

n fo

od

typ

e*††

Ran

gin

g fr

om

150

- 1

170

mg

/

100

g d

epen

din

g o

n fo

od

typ

e*R

ang

ing

fro

m 1

50 -

117

0 m

g /

10

0 g

dep

end

ing

on

foo

d t

ype*

Max

imum

To

lera

ble

Lev

el10

0 m

g /

day

800

IU /

day

†50

IU /

day

††1.

4g /

day

1.4g

/ d

ay

Nut

rien

t Fu

ncti

on

Cla

im P

erm

itte

dE

nhan

ces

abso

rptio

n o

f iro

n fr

om

no

n-m

eat

sour

ces;

co

ntrib

utes

to

th

e ab

sorp

tion

of i

ron

fro

m fo

od

Hel

ps

the

bo

dy

utili

ze c

alci

um &

p

hosp

horu

s; n

eces

sary

for

the

abso

rptio

n an

d u

tiliz

atio

n o

f cal

cium

&

pho

spho

rus

Pro

tect

s th

e fa

t in

the

bo

dy

tissu

es

fro

m o

xid

atio

nA

ids

in t

he d

evel

op

men

t o

f str

ong

b

one

s an

d t

eeth

-

*C

laim

on

fort

ifica

tion

inM

alay

sia

isp

erm

itted

on

vario

ust

ypes

off

oo

ds

fro

mb

read

to

liq

uid

foo

d.

† 1IU

=0

.025

mcg

vita

min

D2

/vi

tam

inD

3††

1IU

=1

mcg

dl-a

lpha

-to

cop

hery

lace

tate

No

te:N

utrie

ntc

ont

enta

ndc

om

par

ativ

ecl

aim

are

per

mitt

ed,f

ollo

win

gC

od

ex;D

isea

seri

skre

duc

tion

clai

mis

no

tper

mitt

ed.P

rovi

sio

no

nfo

rtifi

catio

ncl

aim

ism

ade

inF

oo

dA

ct1

983

(Act

281

)and

Reg

ulat

ions

198

5&

Gui

de

toN

utrit

ion

Lab

elin

ga

ndC

laim

sas

at

Dec

emb

er2

007

und

erF

oo

dS

afet

yan

dQ

ualit

yD

ivis

ion

-M

inis

try

ofH

ealth

Mal

aysi

a.

Tab

le 6

D. R

egul

ato

ry s

tatu

s o

f cl

aim

s o

n o

ther

vit

amin

s an

d m

iner

als

fort

ifica

tio

n in

Mal

aysi

a

Page 26: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

24

Nut

rien

tV

itam

in C

Vit

amin

DC

alci

umP

hosp

horu

s

Fort

ifica

ntA

sco

rbic

aci

d, S

od

ium

asc

orb

ate,

Cal

cium

as

corb

ate,

Po

tass

ium

asc

orb

ate,

Asc

orb

yl-

6-p

alm

itate

Erg

oca

lcife

rol (

Vita

min

D2)

,C

hole

calc

ifero

l (V

itam

in D

3),

Cho

leca

lcife

rol-c

hole

ster

ol (

Vita

min

D3)

Cal

cium

car

bo

nate

, Cal

cium

chl

orid

e,

Cal

cium

citr

ate,

Cal

cium

glu

cona

te, C

alci

um

gly

cero

pho

spha

te, C

alci

um h

ydro

xid

e,

Cal

cium

lact

ate,

Cal

cium

oxi

de,

Cal

cium

p

hosp

hate

mo

no-,

di,

tri-b

asic

, Cal

cium

p

yro

pho

spha

te, C

alci

um s

ulp

hate

Cal

cium

pho

spha

te (m

ono

-, d

i-, t

ri-b

asic

), M

agne

sium

pho

spha

te (d

i-, t

ri-b

asic

), Po

tass

ium

pho

spha

te (m

ono

-, d

i-bas

ic),

Sod

ium

pho

spha

te d

i-bas

ic, P

hosp

horic

ac

id

Min

imum

Acc

epta

ble

Lev

el1/

2 R

DA

(15

mg

) 1/

2 R

DA

(1.2

5 m

cg c

hole

calc

ifero

l)1/

2 R

DA

(250

mg

, to

be

revi

sed

to

400

mg

)1/

2 R

DA

(400

mg

)

Max

imum

To

lera

ble

Lev

el-

10 m

cg o

f cho

leca

lcife

rol /

sp

ecifi

ed

refe

renc

e q

uant

ity24

00 m

g o

f cal

cium

/ s

pec

ified

refe

renc

e q

uant

ity24

00 m

g o

f pho

spho

rus

/ sp

ecifi

ed

refe

renc

e q

uant

ity

Nut

rien

t Fu

ncti

on

Cla

im P

erm

itte

d

(Co

nditi

ons

: mee

t th

e cr

iteria

for

“pre

senc

e o

f” c

laim

(1/6

RD

A))

Enh

ance

s ab

sorp

tion

of i

ron

fro

m

non

mea

t p

rod

ucts

Vita

min

D3:

hel

ps

sup

po

rt c

alci

um

abso

rptio

n an

d im

pro

ves

bo

ne s

tren

gth

; he

lps

the

bo

dy

utili

ze c

alci

um a

nd

pho

spho

rus;

wo

rks

syne

rgis

tical

ly w

ith

vita

min

K o

n b

one

met

abo

lism

to

imp

rove

b

one

str

eng

th/b

uild

str

ong

bo

nes

Hel

ps

bui

ld/t

o s

upp

ort

dev

elo

pm

ent

of

stro

ng b

one

s an

d t

eeth

-

No

te:C

laim

on

fort

ifica

tio

nis

allo

wed

on

foo

dfo

rhu

man

co

nsum

pti

on.

Min

imum

acc

epta

ble

leve

lis

asp

ers

pec

ified

refe

renc

eq

uant

ity.

Nut

rien

tco

nten

tan

dc

om

par

ativ

ecl

aim

sar

ep

erm

itte

d.D

isea

ser

isk

red

ucti

on

clai

mis

no

tp

erm

itte

d.P

rovi

sio

no

nfo

rtifi

cati

on

clai

mis

mad

eb

yA

gri

-Fo

od

&V

eter

inar

yA

utho

rity

of

Sing

apo

rea

sst

ipul

ated

und

ert

heS

ale

of

Foo

dA

ct(C

hap

ter

283,

Sec

tio

n38

(1))

Foo

dR

egul

atio

nsa

ndF

oo

d(A

men

dm

ent)

Reg

ulat

ions

201

1an

dt

heG

uid

eto

Fo

od

Lab

ellin

ga

nd

Ad

vert

isem

ents

201

0.

Tab

le 6

E. R

egul

ato

ry s

tatu

s o

f cl

aim

s o

n o

ther

vit

amin

s an

d m

iner

als

fort

ifica

tio

n in

Sin

gap

ore

Page 27: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

25

Nut

rien

tN

utri

ent

Func

tio

n C

laim

Per

mit

ted

(crit

eria

bas

ed o

n Th

ai R

DI;

nutr

ient

func

tion

clai

m s

tate

men

t in

Tha

i mus

t co

nfo

rm t

o t

he s

tate

men

t th

at is

set

in t

he re

gul

atio

n)

Vit

amin

CSt

reng

then

cap

illar

y w

alls

; hel

p in

inhi

biti

ng fr

ee r

adic

al g

ener

atio

n; a

ssis

t in

the

form

atio

n o

f mus

cle,

co

llag

en a

nd c

onn

ectiv

e tis

sue

of l

igam

ents

and

car

tilag

es

Vit

amin

DR

equi

red

for

the

abso

rptio

n an

d u

tiliz

atio

n o

f cal

cium

and

pho

spho

rus

Vit

amin

EH

elp

in in

hib

iting

free

rad

ical

gen

erat

ion

Vit

amin

KIn

volv

ed in

cre

atin

g t

he im

po

rtan

t su

bst

ance

s in

blo

od

clo

ttin

g p

roce

ss; d

ecre

ase

the

inci

den

ce o

r se

verit

y o

f ost

eop

oro

sis,

cal

cium

re-a

bso

rptio

n a

nd h

elp

str

eng

then

bo

nes

Cal

cium

Ess

entia

l co

mp

one

nt in

bo

nes

and

tee

th;

help

s in

blo

od

clo

ttin

g p

roce

ss; e

ssen

tial f

or

bui

ldin

g h

ealth

y b

one

s an

d t

eeth

Pho

spho

rus

Ess

entia

l co

mp

one

nt in

bo

nes

and

tee

th; e

ssen

tial f

or

bui

ldin

g h

ealth

y b

one

s an

d t

eeth

Mag

nesi

umIm

po

rtan

t st

ruct

ural

par

t o

f bo

nes

and

tee

th;

help

s in

the

mai

nten

ance

the

func

tion

of n

ervo

us s

yste

m a

nd m

uscl

es

Co

pp

erA

ssis

t th

e fo

rmat

ion

of h

emo

glo

bin

Po

tass

ium

Wo

rk t

og

ethe

r w

ith s

od

ium

in m

aint

aini

ng t

he p

rop

er a

cid

-bas

e an

d w

ater

bal

ance

in t

he b

od

y sy

stem

War

ning

: Exc

essi

ve p

ota

ssiu

m c

an b

e to

xic

and

will

affe

ct t

he h

eart

bea

t

Man

gan

ese

Co

mp

one

nt o

f bo

ne a

nd t

eeth

; hel

p p

rom

ote

func

tion

of n

ervo

us a

nd m

uscl

e sy

stem

Sele

nium

Hel

ps

in in

hib

iting

free

rad

ical

gen

erat

ion

Fluo

rid

eH

elp

s p

rom

ote

form

atio

n o

f hea

lthy

bo

nes

and

tee

th

Mo

lyb

den

umH

elp

s p

rom

ote

enz

yme

func

tion

in t

he b

od

y

Chr

om

ium

Wo

rks

tog

ethe

r w

ith In

sulin

for

cellu

lar

glu

cose

up

take

Chl

ori

de

Wo

rks

with

oth

er s

ubst

ance

in m

aint

aini

ng t

he o

ptim

um a

cid

-bas

e b

alan

ce in

the

bo

dy

No

te:C

laim

on

fort

ifica

tion

inT

haila

ndis

allo

wed

on

foo

dfo

rhum

anc

ons

ump

tion.

Min

imum

acc

epta

ble

lim

ito

ffo

rtifi

catio

nto

qua

lify

forf

ort

ifica

tion

clai

mis

an

incr

ease

of1

0%T

haiR

DA

as

com

par

edto

the

refe

renc

efo

od

.No

max

imum

allo

wab

leli

mit

iss

et.

Nut

rient

co

nten

t,c

om

par

ativ

e,a

ndfu

nctio

ncl

aim

sar

ep

erm

itted

inT

haila

ndfo

rall

the

abo

vem

icro

nutr

ient

s,w

ithc

riter

iab

ased

on

Thai

RD

I;nu

trie

ntfu

nctio

ncl

aim

sta

tem

entm

ustc

om

form

toth

est

atem

entt

hati

sse

tin

the

reg

ulat

ion.

Dis

ease

risk

red

uctio

ncl

aim

isn

ot

per

mitt

edin

Tha

iland

.Pro

visi

on

on

fort

ifica

tion

clai

min

Tha

iland

ism

ade

inN

otifi

catio

no

fthe

Min

istr

yo

fPub

licH

ealth

No

.182

/2

541(

1998

),N

utrit

ion

Lab

ellin

gu

nder

Fo

od

and

Dru

gA

dm

inis

trat

ion.

Tab

le 6

F. L

ist

of

oth

er v

itam

ins

and

min

eral

s p

erm

itte

d f

or

fort

ifica

tio

n cl

aim

s in

Tha

iland

(U

noffi

cial

Tra

nsla

tio

n)

Page 28: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

26

Co

untr

yC

amb

od

iaIn

do

nesi

aM

alay

sia

Mo

nito

ring

ag

ency

Min

istr

y o

f Co

mm

erce

thr

oug

h C

amC

ont

rol i

n co

llab

ora

tion

with

re

leva

nt m

inis

try

Nat

iona

l Ag

ency

for

Dru

g a

nd F

oo

d C

ont

rol

Foo

d S

afet

y an

d Q

ualit

y D

ivis

ion

– E

nfo

rcem

ent

Sect

ion

Out

line

of

syst

emSa

lt io

diz

atio

n Io

diz

ed s

alt

mo

nito

ring

In d

istr

ibut

ion/

mar

ket

• S

amp

les:

8 s

amp

les/

bra

nd/v

arie

ty/d

istr

ict/

pha

se

• T

akin

g s

amp

les

in t

he d

istr

ict

rand

om

ly in

the

sub

-dis

tric

t,

v

il ag

e an

d s

elle

r/m

arke

t

Whe

at fl

our

mo

nito

ring

Sam

plin

g p

roce

dur

e ad

op

ted

ISO

824

3:19

91•

Sam

plin

g p

oin

t: S

tora

ge/

harb

or/

imp

ort

er/i

mp

ort

er’s

sto

rag

e/

pro

duc

er, h

yper

mar

ket,

sup

erm

arke

t, s

hop

, sm

all s

hop

/mar

ket.

In t

he d

istr

ict,

sam

ple

s ar

e ra

ndo

mly

tak

en in

the

sub

-dis

tric

t,

v

illag

e an

d s

elle

r/m

arke

t

For

man

dat

ory

and

vo

lunt

ary

fort

ifica

tion:

Foo

d S

afet

y In

form

atio

n Sy

stem

(Fo

SIM

)•

• •

The

tech

nica

l co

mp

eten

t o

ffici

als

that

are

resp

ons

ible

for

cont

rolli

ng t

he s

alt

qua

lity

and

saf

ety

shal

l be

a q

ualit

y co

ntro

l o

ffici

al fr

om

the

Min

istr

y o

f Co

mm

erce

in c

olla

bo

ratio

n w

ith

oth

er re

leva

nt m

inis

trie

s.

The

pla

ces

whe

re t

he in

spec

tion

shal

l be

do

ne a

re s

alt

fact

orie

s,

ente

rpris

e, h

and

icra

ft, s

alt

war

eho

use,

sal

t w

hole

sale

and

reta

il sh

op

s, a

nd a

nyw

here

tha

t d

eal w

ith s

alt

dis

trib

utio

n.

Ow

ner

of f

acto

ry, e

nter

pris

e, h

and

icra

ft a

nd s

alt

trad

ers

shal

l p

rese

nt t

o t

he t

echn

ical

co

mp

eten

t o

ffici

al a

ny re

leva

nt li

cens

e/d

ocu

men

ts w

ith c

lear

ly in

dic

ate

the

typ

e an

d q

uant

ity o

f sal

t su

ch a

s im

po

rtat

ion,

bei

ng u

sed

for

any

pro

duc

tion,

sel

l in

mar

kets

and

in s

tock

.

No

nco

mp

lianc

e w

ith

fort

ifica

tio

n p

roce

ss(a

)

(b)

If sa

lt p

rod

ucer

s an

d d

eale

rs d

o n

ot

follo

w t

he q

ualit

y an

d s

afet

y st

and

ard

s st

ated

If sa

lt p

rod

ucer

s an

d d

eale

rs d

o n

ot

follo

w t

he p

acka

gin

g,

lab

elin

g, s

tora

ge,

tra

nsp

ort

or

mar

ket/

sho

p d

isp

lay

req

uire

men

t

(a)

(b)

Pro

duc

er o

r im

po

rter

do

es n

ot

imp

lem

ent

SNI a

nd p

oss

ess

cert

ifica

tion

Pro

duc

er o

r im

po

rter

do

es n

ot

pas

te S

NI m

ark

on

foo

d

pac

kag

ing

Valu

e le

ss t

han

100%

of t

he d

ecla

red

nu

trie

nt v

alue

on

the

lab

el

Ad

min

istr

ativ

e sa

ncti

on

Pena

lty o

f sal

t co

nfisc

atio

n to

1,0

00,0

00K

R if

the

y ar

e fo

und

of

vio

latio

n th

e su

b-d

ecre

e. T

he p

enal

ty is

do

uble

d a

fter

the

sec

ond

vi

ola

tion

and

the

ir lic

ense

s ar

e su

spen

ded

aft

er t

hird

vio

latio

n.

(a)

(b)

Writ

ten

war

ning

unt

il 3

times

Rev

oca

tion

of a

pp

rova

l reg

istr

atio

n nu

mb

erN

o

Rev

iew

of

reg

ulat

ion

- -

No

Tab

le 7

A. M

oni

tori

ng a

nd E

valu

atio

n o

f M

and

ato

ry F

ort

ifica

tio

n P

rog

ram

s in

Cam

bo

dia

, In

do

nesi

a an

d M

alay

sia

Page 29: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

27

Man

dat

ory

Fo

rtifi

cati

on

Vo

lunt

ary

Fort

ifica

tio

n

Mo

nito

ring

ag

ency

Dep

artm

ent

of H

ealth

thr

oug

h Fo

od

and

Dru

g A

dm

inis

trat

ion

(FD

A) P

hilip

pin

esD

epar

tmen

t o

f Hea

lth t

hro

ugh

Foo

d a

nd D

rug

Ad

min

istr

atio

n (F

DA

) Phi

lipp

ines

Out

line

of

syst

emTh

e lo

cal g

ove

rnm

ent

units

, thr

oug

h th

eir

heal

th in

spec

tors

or

agric

ultu

ral o

ffice

rs

or

nutr

itio

nist

-die

titia

ns o

r th

e sa

nita

ry in

spec

tors

sha

ll as

sist

in m

oni

torin

g/

chec

king

tha

t fo

od

s m

and

ated

to

be

fort

ified

like

ric

e, re

fined

sug

ar, w

heat

flo

ur,

and

co

oki

ng o

il ar

e p

rop

erly

fort

ified

and

lab

eled

with

“nu

triti

on

fact

s” in

dic

atin

g

the

spec

ific

mic

ronu

trie

nt it

was

fort

ified

with

. The

loca

l fo

od

ind

ustr

ies

shal

l rep

ort

o

n th

e p

rod

uctio

n, m

arke

ting

and

dis

trib

utio

n o

f fo

rtifi

ed fo

od

s. T

hey

shal

l sub

mit

annu

al re

po

rts

to t

he D

epar

tmen

t o

f Hea

lth (D

OH

), al

so in

dic

atin

g t

heir

ind

ustr

ial

conc

erns

and

reco

mm

end

atio

ns.

The

FDA

itse

lf o

r FD

A in

co

ord

inat

ion

with

the

reco

gni

zed

ag

enci

es o

r in

stitu

tions

sha

ll m

oni

tor

the

mic

ronu

trie

nt o

f fo

rtifi

ed p

roce

ssed

foo

d.

No

nco

mp

lianc

e w

ith

fort

ifica

tio

n p

roce

ss(a

)

(b)

(c)

If th

e fo

od

fort

ifica

tion

leve

ls d

o n

ot

com

ply

with

the

DO

H re

qui

rem

ents

, exc

ept

whe

n th

e d

evia

tion

fro

m t

he fo

rtifi

catio

n le

vels

are

just

ified

and

are

pro

per

ly

dec

lare

d in

the

lab

elin

g;

If th

e fo

rtifi

cant

use

d is

diff

eren

t fr

om

tha

t ap

pro

ved

by

the

DO

H; a

ndIf

the

pro

cess

of f

ort

ifica

tion

do

es n

ot

conf

orm

to

the

DO

H s

tand

ard

s.

A p

roce

ssed

foo

d c

laim

ing

fort

ifica

tion

shal

l be

cons

ider

ed m

isla

bel

led

unl

ess

the

fort

ifica

tion

leve

ls

com

ply

with

the

se g

uid

elin

es e

xcep

t w

hen

the

dev

iatio

n fr

om

the

fort

ifica

tion

leve

ls h

erei

n se

t ar

e ju

st a

nd a

re p

rop

erly

dec

lare

d in

the

lab

ellin

g.

Ad

min

istr

ativ

e sa

ncti

on

(a)

(b)

(c)

Den

ial o

f reg

istr

atio

n o

f the

pro

cess

ed fo

od

s an

d fo

od

pro

duc

ts b

y th

e D

OH

th

roug

h th

e FD

A if

the

pro

cess

ed fo

od

s o

r fo

od

pro

duc

ts d

o n

ot

com

ply

with

th

e fo

od

fort

ifica

tion

req

uire

men

ts.

Said

pro

cess

ed fo

od

s o

r fo

od

pro

duc

ts s

hall

not

be

allo

wed

to

be

put

in t

he m

arke

t;O

rder

the

reca

ll o

f the

pro

cess

ed fo

od

s o

r fo

od

pro

duc

t(s)

; and

Imp

ose

a fi

ne o

f no

t le

ss t

han

thre

e hu

ndre

d t

hous

and

pes

os

(P30

0,00

0.00

) and

su

spen

sio

n o

f reg

istr

atio

n fo

r th

e fir

st v

iola

tion;

no

t m

ore

tha

n si

x hu

ndre

d

tho

usan

d p

eso

s (P

600,

000.

00) a

nd s

usp

ensi

on

of r

egis

trat

ion

for

the

seco

nd

vio

latio

n; a

nd n

ot

mo

re t

han

one

mill

ion

pes

os

(P1,

000,

000.

00) a

nd c

ance

llatio

n o

f the

reg

istr

atio

n o

f the

pro

duc

t fo

r th

e th

ird v

iola

tion

of t

he p

rovi

sio

ns o

f thi

s ac

t o

r its

Imp

lem

entin

g R

ules

and

Reg

ulat

ions

(IR

R).

(a)

(b)

(c)

(d)

Ord

er t

he re

call

of t

he p

rod

ucts

dec

lare

d/f

oun

d a

s m

isla

bel

led

fort

ified

foo

dO

rder

the

co

rrec

tion

of t

he la

bel

ing

of t

he fo

rtifi

ed fo

od

pro

duc

tsIm

po

se a

dm

inis

trat

ive

fines

pro

vid

ed fo

r b

y ex

istin

g la

ws

Susp

end

or

canc

el t

he re

gis

trat

ion

of t

he p

rod

uct

Rev

iew

of

reg

ulat

ion

The

Nat

iona

l Nut

ritio

n C

oun

cil (

NN

C) s

hall

cond

uct

a p

erio

dic

revi

ew o

f the

m

icro

nutr

ient

s ad

ded

to

foo

d.

This

revi

ew w

ill p

rovi

de

the

bas

is fo

r d

eter

min

ing

if

the

man

dat

ory

fort

ifica

tion

is s

till r

equi

red

or

not.

The

revi

ew s

hall

be

do

ne a

t le

ast

ever

y fiv

e (5

) yea

rs t

o c

oin

cid

e w

ith t

he c

ond

uct

of t

he F

oo

d a

nd N

utrit

ion

Res

earc

h In

stitu

te’s

(FN

RI)

natio

nal n

utrit

ion

surv

eys

and

/or

the

asse

ssm

ent

of t

he P

hilip

pin

e Pl

an o

f Act

ion

for

Nut

ritio

n (P

PAN

).

Tab

le 7

B. M

oni

tori

ng a

nd E

valu

atio

n o

f M

and

ato

ry a

nd V

olu

ntar

y Fo

rtifi

cati

on

Pro

gra

ms

in t

he P

hilip

pin

es

Page 30: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

28

Nut

rien

tB

read

*B

reak

fast

cer

eal

(as

pur

chas

ed)*

Co

nden

sed

milk

*†D

ried

milk

p

ow

der

(ful

l cre

am

or

skim

med

)*

Ext

ract

of

mea

t o

r ve

get

able

(m

od

ified

o

r no

t)*

Flo

ur(w

heat

)*M

alte

d m

ilkp

ow

der

*O

ther

so

lid

foo

d*§

Liq

uid

fo

od

Vit

A,

vit

A a

lco

hol a

nd e

ster

s,

caro

tene

s (I.

U.)

**

500

2000

670

2000

12,0

0010

0040

0010

0010

00

Vit

B1

, th

iam

ine,

thi

amin

e hy

dro

ch

lori

de,

thi

amin

e m

ono

nit

rate

(m

g t

hiam

ine)

0.21

0.83

0.82

0.83

50.

421.

670.

420.

25

Vit

B2

, ri

bo

flav

in

(mg

rib

ofl

avin

)0.

331.

330.

441.

338

0.67

2.67

0.67

0.4

Vit

B6

, p

yrid

oxi

ne,

pyr

ido

xal,

pyr

ido

x am

ine

(mg

pyr

ido

x am

ine)

0.42

1.67

0.56

1.67

100.

833.

330.

830.

5

Bio

tin

(mcg

bio

tin)

4016

555

165

1000

8533

585

50

Pan

to t

heni

c ac

id,

pan

to t

heny

l al

coho

l (m

g p

anto

the

nic

acid

)1.

465.

831.

945.

8335

2.92

11.6

72.

921.

75

Nia

cin,

nia

cin

amid

e, n

ico

tini

c ac

id,

nico

tin

amid

e (m

g n

iaci

n)2.

39.

23.

19.

255

4.6

18.3

4.6

2.8

Vit

C,

asco

rbic

aci

d

(mg

asc

orb

ic a

cid

)6

258

2515

013

5013

8

Vit

D,

vit

D2

, vi

t D

3

(I.U

. o

f vi

t D

)**

8333

311

133

320

0016

766

716

710

0

Vit

E,

alp

ha t

oco

phe

rol

(I.U

. o

f vi

t E

)**

4.2

16.7

5.6

16.7

100

8.3

33.3

8.3

5

Cal

cium

(m

g)

150

580

190

580

3500

290

1170

290

180

Iod

ine

(mcg

)20

8530

8550

040

165

4025

Pho

spho

rus

(mg

)2.

10.

32.

84.

350

4.2

16.7

4.2

2.5

Folic

aci

d (

mcg

)15

058

019

058

035

0029

011

7029

018

0

Vit

B1

2 (

mcg

)8

3211

3219

216

6416

9.6

Bas

edo

nR

egul

atio

n26

(7)u

nder

Fo

od

Act

198

3(A

ct2

81)a

ndR

egul

atio

ns.

*R

efer

ence

qua

ntity

:100

gra

ms.

†Sw

eete

ned

and

uns

wee

tene

d;fi

lled

milk

and

co

nden

sed

fille

dm

ilks

wee

tene

da

ndu

nsw

eete

ned

No

tsp

ecifi

eda

bo

vee

xclu

din

gc

anne

dfo

od

for

infa

nts

and

chi

ldre

nan

dc

erea

lbas

edfo

od

for

infa

nts

and

chi

ldre

n.¶

In

clud

ing

veg

etab

leju

ice,

frui

tju

ice,

frui

tju

ice

conc

entr

ate,

frui

tsy

rup

,flav

our

eds

yrup

(dilu

ted

acc

ord

ing

to

dire

ctio

ns).

**M

ayb

eex

pre

ssed

inm

illig

ram

so

rmic

rog

ram

sus

ing

the

follo

win

gc

onv

ersi

on

fact

or:

1IU

vita

min

Ais

eq

uiva

lent

to0

.3m

icro

gra

ms

vita

min

Aa

lco

hol(

retin

ol);

1IU

vita

min

Dis

eq

uiva

lent

to0

.025

mic

rog

ram

svi

tam

inD

2/vi

tam

inD

3;1

IUv

itam

inE

ise

qui

vale

nt

to1

mill

igra

md

l-alp

ha-t

oco

phe

ryla

ceta

te.

Tab

le S

1. M

inim

um A

mo

unts

of

Nut

rien

ts f

or

Fort

ifica

tio

n C

laim

s in

Mal

aysi

a

Page 31: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

29

Disclaimer: This report is made available solely for the purpose of information and is accurate as of July 2011. It has no legal value. Users are advised to verify any information obtained from this report or on updates with the official sources. While we have endeavored to ensure that the information contained in this publication is accurate, ILSI Southeast Asia Region is not liable to any error or omissions.

Page 32: REPORT ON REGULATORY STATUS OF MICRONUTRIENT FORTIFICATION ...ign.org/...Region_Report_-_Micronutrient_Fortification_Regulations.pdf · OF MICRONUTRIENT FORTIFICATION ... food-based

http://www.ilsi.org/SEA_Region

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