Technical Guidance on Rice Fortification

%/ %/5 wh eis ၂ | Technical Guidance on Rice Fortification Technical Guidance on Rice Fortification Ministry of Health and Sports February 2019 (Version - 1) Technical Guidance on Rice Fortification Contents 1. ဓ (၂၂ ၂၂၂ ၂111111111111111111111111111111111111111:1 1 2. Eligibility Criteria for Producing Fortified Rice and Using Category Brand and Quality Seal 2... ee ee ee ee tee eet teens tee 1 3. Procedure for Producing Fortified Rice Using the Fortified Rice Category Brand and Quality Seal... 2... ce ec ee eee ee eee tee eee teens 2 4. Category Brand ၂၂၈၇၂ ဃ ၂၂၂၅၂ ၂၅၂၂၅111111111111111111111:; 2 Annex A. Composition of Fortified Rice in ၇). ၂၂၂ ၂၂11 11111111111111111; 3 General Composition... | | ၂ ၂၂1 eee ee ee ee ee nes 3 Detail Composition... | ၂ ၂ ၂၂၂1! 111111111111111111111111111;1 3 Annex B. Fortified Rice Production Quality Control Process..............e2000- 5 PUPPOSE | | | ၂ 1 1 11 111 111 11111111111111111111111111111111 5 Standard Production of Fortified {၈၁ ၇ ၇၂၂၇11 1၅111111111111 6 Proposed Quality Control Process ၂ | ၂ | ၂၇ ၂ 1၂111 eee ee ee eee ns 7 Annex င. Guide to Fortified Rice Category Brand and Quality Seal............. 8 Characteristics of Fortified Rice Category Brand and Quality Seal........ 8 Category Brand... 1... ee ee ee eee ee eee 8 Quality Seal... ee ee ee eee eee eee 9 References... . 2... cc ew we ww ee we et we ew ee ew ee eee ee ee ete twee 10 Technical Guidance on Rice Fortification 1. Background The Government of Myanmar has been implementing the nutrition promotion program through 5-yearly National Plan of Action on Nutrition [1] [2] to improve the nutritional status and overall health of its citizens. The plan identifies food fortification as one of the approaches to reduce micronutrient deficiencies [3] which are amongst the major nutrition problems in Myanmar. Rice is one of the best vehicles for food fortification [41, as it is the staple food of the general population of Myanmar [9], Accordingly, the National Nutrition Centre under the Ministry of Health and Sports with support from PATH and in coordination with all stakeholders has initiated the introduction of fortified rice in Myanmar since 2013. The national-level Rice Fortification Working Group (RFWG) was formed with the public, private and social sector partners to guide the process and to provide technical support to the implementing partners. RFWG has approved micronutrient content specifications and quality control mechanism for rice fortification in 2014. It also recommends the use of category brand, quality seal and eligibility criteria for the purpose of introduction of rice fortification in Myanmar. Fortified Rice Fortified rice is produced by blending fortified rice kernels with traditional rice at a ratio of 1:99 [01[7]. It is intended to be as close as possible to traditional rice in smell, taste, and texture. In this technical guidance, fortified rice kernels refer to premade micronutrient kernels that are produced by blending rice flour and premix (commercially prepared blend of vitamins and minerals) through an extrusion method [01[7][81. The composition of fortified rice, micronutrient content specifications and quality control mechanism in Myanmar that are described in this guidance are endorsed by RFWG on December 16, 2014 (see Annex A & B). 2. Eligibility criteria for producing fortified rice using the fortified rice category brand and quality seal A rice miller who plans to produce fortified rice in Myanmar must meet following criteria: i. Be a registered rice miller or trader. ii. Be able to demonstrate by principle and practice the adoption, implementation, and recording of good manufacturing practices, good hygienic practices, and a hazard analysis critical control point program. iii. Present evidence of purchase of fortified grains from a fortified grain supplier or a statement of the miller’s own production of those grains, if applicable. iv. Produce fortified rice products in accordance with the standards endorsed by RFWG and established by NNC (please see Annex B "Fortified Rice Production Quality Control Process - Fortified Rice Production Process") v. Submit samples of its fortified rice products to NNC and the Myanmar Food and Drug Administration (FDA) as part of initial quality verification and according to the fortified rice production quality control process (Annex B) OR upon request by NNC or FDA. (1) Camm Technical Guidance on Rice Fortification Vi. Vii. Allow NNC, FDA, or their designated body to have access to the miller’s facilities for quality audits, as part of the quality verification process. Promptly address any process or product quality issues identified by the NNC or FDA in its quality verification process. 3. Procedure for producing fortified rice using the fortified rice category brand and quality seal A rice miller who plans to produce fortified rice in Myanmar needs to submit an information package that includes the following: i. ii. iii. Vi. Evidence of permission under respective national law to operate as a rice miller or trader. Evidence of purchase of fortified grains from a fortified grain supplier or statement of the miller’s own production of those grains, if applicable. Submission of samples of its fortified rice products to NNC and FDA as part of initial quality verification. . Company quality control manual. Evidence that packaging follows food-labeling practice with the use of the fortified rice category brand and quality seal. A signed disclaimer in which the miller assumes final and legal responsibility for the quality of the verified product, pursuant to the legislation in effect. 4. Category Brand and Quality Seal [9] The category brand အားဖြည်ဆန် was created to assist consumers to identify fortified rice. The quality seal was created to assure consumers that the quality of fortified rice meets the national composition standard endorsed by NNC. (2) Technical Guidance on Rice Fortification Annex A. Composition of Fortified Rice in Myanmar General Composition [1°] စ Components: iron, zinc, vitamin A, thiamin, niacin, vitamin B6, folic acid, vitamin B12. စ Amount: 100 percent of estimated average requirement of males aged 19 to 50 years old. Detail Composition The detail composition recommendation is based on “Proposing nutrients and nutrient levels for rice fortification” by Saskia de Pee [11], which thoroughly assessed the nutritional requirements of different population subgroups and the bioavailability of each nutrient compound added to fortified rice. Based on the rice consumption level in Myanmar, the composition of fortified rice should be >300 mg/d level [12], Table Nutrient levels proposed for fortified rice at moment of consumption (mg/100 g)* Nutrient Compound? <75pgid 75-149p/d 150-300g/d| >300g/d EAR? Iron‘ Micronized ferric 12 12 7 7 pyrophosphate Folic acid¢ Folic acid 0.50 0.26 0.13 0.10 0.192 Vitamin B124 —Cyanocobalamin 0.004 0.002 0.001 0.0008 0.002 Vitamin A? Vitamin A palmitate 0.59 0.3 0.15 0.1 0.357 (f) 0.429 (m) Zinc Zinc oxide 9.5 8 6 5 8.2 (f) 11.7 (m) Thiamin’ Thiamin mononitrate 2.0 1.0 0.5 0.35 0.9 (f) 1.0 (m) Niacin’ Niacinamide 26 13 7 4 11 (f) 12 (m) Vitamin B6f — Pyridoxine hydrochloride 2.4 1.2 0.6 0.4 1.1 *Source: Steiger et al.’ *It is important to note that these fortification levels aim at providing the EAR (estimated average requirement) by the particular food, which is in line with the WHO/FAO guidelines for micronutrient fortification.*> When other mass fortification programs are implemented effectively as well, the suggested fortification levels may have to be adjusted downwards. “Concentration of 7 mg/100 ၉ is proposed for both the 150-300 g/d and >300 g/d categories because there are limited data about the effectiveness of iron fortification of rice, choice of iron compounds suitable for rice fortification is limited, and iron deficiency and anemia are important reasons to implement rice fortification. For the <75 p/d and 75-149 g/d categories, the level is almost twice as high. It is important to note that these levels require blending at a higher ratio, such as 1.5:100 or 2:100 in order not to have a fortified kernel that can be distinguished from unfortified kernels. Also, organoleptic properties of this concentration need to be assessed. “Concentrations are the same as recommended for wheat and maize flour.'* “Concentrations have been set between those recommended for high- and low-extraction flours and at a level that keeps the ratio with iron close to 1. ‘Concentrations have been set such that they provide the EAR, which is comparable to the levels proposed for folic acid and vitamin B12. £These are targets for consumption. Overages may be added for specifications for production, and ranges can be set for assessing compliance with specifications. (3) Technical Guidance on Rice Fortification Composition of fortified rice Target Amount fortification recommended level, for rice Targeted including Target Expected Nutrient consumption amount in | 30% overage range range at (Fortificant) Compound Form of >300 100 g for ex- household g/cap/d, uncooked rice] vitamins to factory level in ppm compensate (mg/100 g) storage losses . န Vitamin A 100.0 mcg 115.00- 100.00- 1 . Vitamin A | palmitate 0.1000 (rE) | 130-00 ဂဇ | 145.00 160.00 Vitamin B1 | Thiamin 0.3500 0.35 mg 0.46 mg | 0.40-0.52 | 0.30-0.60 (Thiamin) mononitrate Vitamin B12 |Cyanocobalamin 0.0008 0.8 mcg 1.04 mcg | 0.90-1.20 | 0.80-1.30 Folic acid . န 110. 00- စြ Folic acid 0.1000 100.0 mc 130.00 mc 100.00 (B9) olic aci g ဒိ 150.00 160 00 Iron (Fey |Micronized ferric 7၇၉000 7.00 mg 7.00 mg | 6.00-8.00 | 6.00-8.00 pyrophosphate " ” . ” ” ” ” Zinc (Zn) Zinc oxide 5.000 5.00 mg 5.00 mg | 4.50-5.50 | 4.50-5.50 Niacin Niacinamide 4.000 4.00 mg 5.20 mg | 4.50-6.00 | 4.00-6.50 န န Pyridoxine Vitamin B6 hydrochloride 0.4000 0.40 mg 0.52 mg | 0.45-0.59 | 0.35-0.70 Source: Sasika. de Pee Proposing nutrients and nutrient levels for rice fortification. Annals of the New York Academy of Sciences. 2014;1324:55-66. doi: 10.1111/nyas.12478. Notes: 1. The iron fortificant that can be used in rice is ferric pyrophosphate. Other fortificants, such as Ferric Sodium Ehtylenediaminetetraccetate (NaFeEDTA) and ferrous fumarate, produce a brown-colored kernel. 2. Target range ex-factory applies +/- 10 percent and rounding. 3. The expected range at household level (or anywhere in the supply chain) is for the targeted amount of vitamins as the minimum and ex-factory maximum as the maximum. For minerals, the ex-factory range is taken. 4. The target and expected range cannot be used for quality control because the variation of the concentration in a sample of fortified rice may be beyond the specified range; this is due to the fact that fortified kernels are blended with normal rice at a ratio of 1:99, which is equivalent to approximately 50 fortified kernels per 100 g. Thus, a 100 g sample with less than 45 or greater than 55 fortified kernels already will be outside the target range. 5. Quality control is best done on fortified kernels while applying a larger range of permitted concentration to fortified rice. (4) Technical Guidance on Rice Fortification Annex B. Fortified Rice Production Quality Control Process Purpose A clear and formal process for fortified rice quality verification is one of the cornerstones for the creation of a sustainable, credible, and effective fortified rice market in Myanmar. Defining, enabling, implementing, and sustaining this process and the associated standards will inspire the confidence of consumer and retailers, and will support rice millers in supplying a high-quality product to the market. This quality control process should underlie the granting of the fortified rice quality seal to products that abide by rice fortification standards. Guiding Principles Technical soundness and quality. The quality control process should be technically robust and consistent with quality control principles and procedures prevalent in the food industry. The product specifications (either for the fortified kernels or the fortified rice product, or both) must be validated by an accredited laboratory which adheres to a set protocol for testing of the micronutrient content. The raw materials used in the production of fortified grains must be good quality and meet Food and Drug Administration (FDA) food safety standard. Simplicity and cost-effectiveness. The quality control process should avoid non-value adding complexity and imposing unnecessary burdens on grain producers, rice millers and the implementing entity. It should be simple to understand and simple to implement, and should have minimal impact on the cost structure of fortified rice in Myanmar. Transparency. The quality control process should be clearly defined and its description publicly available. A baseline. The micronutrient content standards associated with the quality control process should reflect the minimal set of micronutrients to be present in any verified fortified rice product commercialized in Myanmar as recommended by National Nutrition Center (NNC), Department of Public Health, Ministry of Health and Sports. Visibility. Fortified rice brands qualified through this process should be granted the right to use, and be distinguished by, a standard fortified rice quality seal in their packaging and marketing communications. Self-sustainability. To ensure the long term viability of the quality control process, it should be self-funded by grain producers and rice millers. (5) Technical Guidance on Rice Fortification Standard Production of Fortified Rice [13] The figure below describes the quality control process of fortified rice. Milled Fortified Rice Rice Blend 0.5%-2.0% Paddy Rice <> ratio Broken/ Fortified Head Rice Kernels Add vitamins & minerals (premix) Rice Mill Rice Mill There are two key sets of standards covered by the quality control process: e Micronutrient content standards: These standards specify the minimal set of micronutrients and the appropriate levels of each micronutrient that should be present in any fortified kernel in Myanmar. စ Blending ratio standard: This specifies the standard blending ratio that a rice miller must meet in producing fortified rice brands. Fortified Rice Production Process | Premix was imported by Grain producer from qualifier supplier | ` Premix was mixed with rice flour and fortified kernels is produced locally by hot extrusion machine ` | End product - Fortified Kernels | v | Rice Millers purchase the fortified Kernels from Grain Producers | ` Fortified Kernels is blended with normal rice (1:99 ratio) by blender unit ၇ | End product - Fortified Rice | Vv | Distribute into market | ~ | Consumers | (6) Technical Guidance on Rice Fortification Proposed Quality Control Process [141[15][16)[17][18}[19)[20][21][22] Internal Process External Who When Where Who When Where Fortified | Foreach |Factory 1. Imposing quality control | FDA (in Import At grain premix on the premix to ensure collaboration |recommenda | importa- producer | import that specifications are with NNC) tion—first tion site met (Obtain certificate of import and analysis for every delivery every 2 years of the premix Fortified | Monthly Factory | 2. Establishing quality grain control measures for premix producer handling and storage Fortified | Daily Factory | 3. Establishing good FDA Start of Factory grain manufacturing practice, factory producer good hygienic practice running Fortified | Daily Factory | 4. Record keeping of all the grain quality control activities for producer the fortified products Fortified | 6-monthly |Factory | 5.Routinely undertaking FDA, Annually FDA lab, grain analyses of the fortification | NNC NNC lab producer level of the fortified products Fortified | Foreach |Rice mill | 1. Imposing quality control rice fortified on the fortified rice kernels producer | kernels to ensure that specifications purchase are met Fortified | Monthly Rice mill | 2. Establishing quality rice control measures for producer fortified rice kernel storage Fortified | Daily Rice mill | 3. Establishing quality rice control on the blending producer process and ratio Fortified | Daily Rice mill | 4. Record keeping of all the rice quality control activities for producer the fortified products 5. Routinely undertaking FDA, Annually At analyses of the blending NNC retailer ratio Abbreviations: FDA, Myanmar Food and Drug Administration; NNC, National Nutrition Center. (7) Technical Guidance on Rice Fortification Annex C. Guide for Fortified Rice Category Brand and Quality Seal Characteristics of fortified rice category brand and quality seal [23] The fortified rice brand name Arr-phyae-san and its visual identity were created in response to the challenge of attracting a very specific type of consumer. In order for brand awareness to reach its maximum potential, the visual presentation of a brand across all media at local, national, and international levels must be carefully managed. Visual consistency plays a fundamental role in increasing recognition of the services and products provided by the brand. The purpose of this guidance is to provide a holistic standard for the presentation of the fortified rice category brand and quality seal across an entire range of visual media. Category Brand ce ရာ အျားဖြည်ဆ The brand name should never use colors other than those specified in this manual and should always be created from original, digital artwork and never redrawn. Minimum Size The fortified rice category brand name must not be reproduced at a size smaller than 70 mm in length. Color Treatment There is one preferred full-color option. Packaging General arrangement, front of the package The preferred position for the logo on the front of the package is at the middle (vertically), right (horizontally), of the package, but the middle (vertically), center (horizontally) is also acceptable if the existing package design requires it. General rrangement, back of the package The preferred position for the logo on the back of the package is the top left area, but a top center location is acceptable. (8) Technical Guidance on Rice Fortification Quality Seal Guidelines The seal should never use colors other than those specified in this manual and should always be created from original, digital artwork and never redrawn. All elements within the seal variations must remain at their fixed proportions and should not be scaled, repositioned, or altered in any way. Construction The graphic element is made up of two parts: (1) the central element is a rice grain wreath coming together in the shape of a heart within (2) a green shield. Family The quality seal is well proportioned and therefore available only in its stacked version with the height to width ratio of 6 to 5. Clear Space The minimum clear space or margin for the fortified rice quality seal is based on the 5 mm version of the seal. On all sides, the minimum clear space should be measured from the farthest edge of the seal. No element, other than the tagline, may encroach on this space. Minimum Size The fortified rice quality seal must not be reproduced at a size smaller than 20 mm in height. (Marberly 2011) (Rizwan Yusufali 2015) (Carmen Forsman 2014) Color treatment There is one preferred full-color option. The seal on the yellow field should be used whenever possible. The seal should not be placed on another color without the yellow field or reversed out of either color or imagery. Packaging General arrangement front and back: The preferred position for the seal on the front is at the bottom right of the package, but the bottom center is also acceptable if the existing package design requires it. (9) Technical Guidance on Rice Fortification References 1. National Plan of Action on Food and Nutrition 2011-2015 (NPAFN 2011-2015) Multi-Sectoral National Plan of Action on Nutrition 2018-2022 (MS-NPAN 2018-2022) Myanmar Demographic and Health Survey 2015 (MDHS 2015) လ ယ DN Guideline: Fortification of Rice with Vitamins and Minerals as a Public Health Strategy by WHO, 2018. 5. Landscape Analysis of Myanmar Rice Sector for Development of Rice Fortification Policy 2017, conducted by Dr Aye Thwin. 6. George Steiger, Nadina Muller-Fisher, Hector Cori, Beatrice Conde-Petit. "Fortification of Rice: Technologies and Nutrients. “Annals of the New York Academy of Sciences, 2014. 7. Sajid Alavi, Betty Bugusu, Gail Crameer, Omar Dary, Tung-Ching Lee, Luann Martin, Jennifer McEntire, Eric Wailes. "Rice Fortification in Developing Countries: A Critical Review of the Technical and Economic Feasibility.”, USAID, 2008. 8. Marbely, Glen F. “Rice Fortification: A Key Part of the Solution to Micronutrient Deficiencies.” Washington DC: Centre for Health Innovation and Partnership, 2011. 9. Labeling and packaging Guidelines endorsed by Rice Fortification Working Group 10. Guidelines on Food Fortification with Micronutrients, WHO and FAO, 2006. 11. Pee, Saskia De. "Proposing Nutrients and Nutrient Levels for Rice Fortification.” Annals of the New York Academy of Sciences, 2014. 12. Asia's Next Rice Granary: Myanmar? LIFT-Fund Myanmar, 2012. Original article available at http://irri.org/index. php?option=com k2&view=item&id=12396:asia%E2 %80%99s-next-rice-granary-myanmar?&lang=en 13. Rizwan Yusufali, Katrien Ghoos, Peiman Milani, Jennifer Rosenzweig. Scaling Up Rice Fortification in Asia. July 2015. 14. Corey LLuthringer, aLaura A Rowe, b Marieke Vossenaar,a Greg S Garretta, “Regulatory Monitoring of Fortified Foods: Identifying Barriers and Good Practices”, Global Health: Science and Practice 2015 | Volume 3 | Number 3 15. Food Fortification Initiative, report on 2014 yearly review 16. Luz M. De-Regil, Juan Pablo Pe™na-Rosas,1 Arnaud Laillou, and Regina Moench- Pfanner, “Considerations for rice fortification in public health: conclusions of a technical consultation”, Ann. N.Y. Acad. Sci. 1324 (2014) 1-6 C 2014 The New York Academy of Sciences 17. Carmen Forsman, Peiman Milani,1 Jill A. Schondebare, Dipika Matthias, and Christophe Guyondet, “Rice fortification: a comparative analysis in mandated settings”, Ann. N.Y. Acad. Sci. 1324 (2014) 67-81 @ 2014 New York Academy of Sciences 18. Report of the joint WHO, UNICEF, FFI, GAIN, MI, and World Bank meeting on regulatory monitoring of salt and flour fortification programmes in Asia. ManilaPhilippines, September 2011, WHO, 2013 (10) 19. 20. 21. 22. 23. Technical Guidance on Rice Fortification Annoek van den Wiingaart, “Regulatory monitoring systems of fortified salt and wheat flour in selected ASEAN countries”. Food and Nutrition Bulletin, Vol 34, NO. 2, 2013. Report on regulatory status of micronutrient fortification in South-East, ILSI, 2011. “Monitoring and Evaluating Food Fortification Programs: General Overview, Technical Consultation, July, 2006, USAID 2008. Lindsay H. Allen, “New Approaches for Designing and Evaluating Food Fortification Programs”, J. Nutr. April 2006 vol. 136 no. 4 © 2006 American Society for Nutrition. Fortified Rice - Packaging, Labeling and Brand Requirement Guidelines which is endorsed by Rice Fortification Working Group in 2015, July. (11) Livelihoods and Food Security Fund SS တား အလေ UKaid from the British people European U nion " ၂၅၂၂၂. 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