TRAINING MANUAL PUBLIC SECTOR REGULATORY MONITORING STAFF 1
Wheat (Triticum aestivum) is an imperative food crop o Energy o Vital nutrients (up to 60%) o Staple diet In Pakistan, wheat production and average wheat grain yield is 25.482 million tonnes and 2,752 kg per hectare Wheat Consumption in Pakistan is >300g/day (Economic survey of Pakistan, 2015-16) More than 50% of total energy intake is derived from cereal products Dr. Imran Pasha, NIFSAT, UAF 2
Cereals 70% Maize 22% Rice 16% Wheat 21% Others 11% 7% 6% 3% Sugar 4% 8% Animal & fish products Legumes, oilseeds Roots & tubers Fruits 2% Other Vegetables & melons Dr. Imran Pasha, NIFSAT, UAF 3
Children Severely Underweight 39% Stunted Growth 36.8% Iron Deficiency 66.5% Vitamin A Deficiency 12.5% Zinc Deficiency 37% Severe Iodine Deficiency 23% RDA of Iron 8-11mg/day (NNS, 2011) Dr. Imran Pasha, NIFSAT, UAF 4
Women Iron Deficiency 45% Zinc Deficiency 5.9% Iodine Deficiency 20% Vitamin A Deficiency 6.5% (NNS, 2011) RDA of Iron 8-27mg/day Dr. Imran Pasha, NIFSAT, UAF 5
Impact of Malnutrition 177,000 deaths per annum due to maternal nutrition, breasfeeding behavior and Micronutrient deficiencies Future work force losses are $2.24 billion/year US$ 657 million loss/year- due to anemia (labour involved in agriculture, industry) Cost of health care services due to Zinc deficiency, suboptimal breastfeeding and low birth wt is estimated US$ 1 billion /year Dr. Imran Pasha, NIFSAT, UAF 6
Food based strategies are most effective and sustainable approach to combat micronutrients deficiencies. Three major strategies have been in place to address the issue Food diversification Supplementation Food fortification Dr. Imran Pasha, NIFSAT, UAF 7
More economical, flexible and socially acceptable Global success history; improved nutrition in a number of developed countries Adding vitamins and minerals to flour during the milling process May include nutrients naturally in the grain or additional nutrients Fortification vehicles are easily accessible Designed for mass populations Copenhagen Consensus include Micronutrient fortification among 10 strategies Dr. Imran Pasha, NIFSAT, UAF 8
Per capita wheat consumption in Pakistan is among the highest in the world an ideal carrier Wheat flour relatively easy for fortification as we can blend small amount of essential micronutrients As the wheat flour is the staple diet Iron fortification has no adverse effect on the quality, organoleptic characteristics of unleavened flat bread The concentration of iron fortification in the cereal foods can range from 25ppm - 80ppm. Loss in the concentration during milling process, available micronutrients. Dr. Imran Pasha, NIFSAT, UAF 9
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Grinding Sieving Purification Flour handling and grading Dr. Imran Pasha, NIFSAT, UAF (IARP, 2014) (PFMA) 11
In the Break System Open the wheat kernel Remove the endosperm and germ from the bran coat With the least amount of bran contamination Obtain a granulation distribution of maximum large middlings with a minimum of flour and fine middlings that cannot be purified before reduction into flour In the Sizing System The objective of grinding in the sizing system: Detach the bran pieces attached to the large middlings (endosperm particles with various degrees of attached bran) Produce clean middlings, while minimizing flour production Dr. Imran Pasha, NIFSAT, UAF 12
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Separation of a ground mass of material into various particle-size classifications In the flour mill, sieving after each grinding operation classifies the material for the subsequent step) and removes the flour produced in the grinding operation Separate particles by size Gyrating box sifters Reciprocating sieves Reel-type machines Dr. Imran Pasha, NIFSAT, UAF 14
Gyrating sifter drive Combination reciprocating and gyrating sifter Dr. Imran Pasha, NIFSAT, UAF 15
Leverage Existing Infrastructure to Reach Population Grain milling is a centralized business with broad distribution of products Foods made with wheat and maize are widely consumed Consequently, fortification has the potential to reach millions of people. Dr. Imran Pasha, NIFSAT, UAF 16
Mineral loss at 75-80% extraction Dr. Imran Pasha, NIFSAT, UAF 17
Fortification Standards for Pakistan Fortificant Form Level Iron Sodium Iron EDTA (NaFeEDTA) Not less than 15 PPM Zinc Zinc Oxide (ZnO2) Not less than 30 PPM Folic Acid Folic Acid (Folate) Not less than 1 PPM Vitamin B12 Cyanocobalamin (B12) Not less than.008 PPM Dr. Imran Pasha, NIFSAT, UAF 18
The most common flour fortification practice is to add multiple vitamins and minerals using a single ingredient called a premix (already mixed) Premix includes: Fortificants (powdered vitamins and minerals) Excipients (carriers, fillers) Free-flow agent Premix may have a yellow, brown to green color. This does not affect the color of flour because premix is added in such small amounts. Dr. Imran Pasha, NIFSAT, UAF Photo courtesy of Hexagon Nutrition 19
Easier to test Single feeder, check and adjustment Easier to feed Provides uniform nutrient distribution Single ingredient tracer possible Less expensive than buying individual nutrients Individual nutrients, such as these pictured, are more difficult to add to flour than a single premix with a blend of the required nutrients. Photo courtesy of WIN, World Initiative for Nutrition, a business unit of Fortitech Dr. Imran Pasha, NIFSAT, UAF 20
Elemental Iron (reduced iron or electrolytic iron) Ferrous Sulfate Ferrous Fumarate Sodium Iron EDTA (NaFeEDTA) Dr. Imran Pasha, NIFSAT, UAF 21
Iron Source Concentration Color Relative of Fe (%) Bioavailability Ferrous sulfate 32 White 100% Ferrous fumarate 33 Red 100% Ferric 28 Yellow 25-32% orthophosphate Reduced iron 97 Black 13-148% Electrolytic iron 98 Dark grey 5-100% Sodium Iron EDTA 13 Brown 150-300% Ferrous bisglycinate 20 Grey-green 100% Dr. Imran Pasha, NIFSAT, UAF 22
Bioavailability (absorption) Water soluble compounds have the highest relative bioavailability because they are very soluble in gastric juices. The size, shape and surface area of the iron particle affects bioavailability, as does composition of food made with fortified flour. Sensory changes High levels of some iron compounds could cause coloration or rancidity of the flour. Cost: Highly bioavailable forms of iron are more expensive, but less is needed per metric ton of flour for fortification to have a health impact. Dr. Imran Pasha, NIFSAT, UAF 23
Sodium-iron-EDTA for wheat flour enrichment or fortification should be a USP/FCC grade. It is a brownish yellow powder Assay EDTA 66.0-71.0% Fe (III) 12.5-14.0% ph (1%) 3.5-5.5 Water-insoluble matter 0.1% Max. Chloride 0.05% Max. Sulfate 0.2% Max. Arsenic 0.0003% Max. Lead 0.001% Max. Source: Dr. Paul Lohmann Chemicals, Germany Dr. Imran Pasha, NIFSAT, UAF 24
Packaging, storage, and handling the premix Premixes are concentrated sources of iron or other micronutrients Excessive intake of iron in a single dose is poisonous and can be fatal; lower concentrated doses over a prolonged period can also be harmful Boxes must be carefully labeled Not suitable for direct consumption Operators at mill should take precautions such as wearing a dust mask, gloves, etc. to prevent inhalation of and exposure of skin to the premix or iron fortificant Dr. Imran Pasha, NIFSAT, UAF 25
Packaging, storage, and handling the premix The premix and iron fortificant must be properly handled to minimize degradation of the compound Must be stored in well-ventilated rooms at low or mild temperatures (preferably not higher than 25 C), and exposure to humidity must be avoided The amount of commercial premix or iron fortificant needed should be estimated and obtained in quantities small enough so that it does not need to be stored for long periods of time The production lot number(s) should be properly recorded Premix should beused on a first-in/first-out basis Once a commercial premix or iron fortificant box has been opened, it should be used within the period specified for its shelf life Dr. Imran Pasha, NIFSAT, UAF 26
Premix is usually added to flour using one of two procedures: Continuous Batch The gravity-based system such as the one pictured here is an example of premix being added to flour continuously as it is produced at the mill. Dr. Imran Pasha, NIFSAT, UAF 27
Premix is continuously added to the flour stream using a feeder feeder Premix addition is proportional to the rate of flour production Validation of mixing uniformity is required conveyor Premix can be continuously added into a collection conveyor such as the one shown here. Dr. Imran Pasha, NIFSAT, UAF 28
Premix is generally added to a batch of flour via a gravity spout and blended in a mixer Premix addition is based on flour batch size Operation can be manual or automatic Validation of mixing uniformity is required Dr. Imran Pasha, NIFSAT, UAF Batch mixer photo courtesy of Buhler Company 29
Premix Feeder Mixing Mechanism Measures correct amount of premix Position at appropriate place in production line Can be done during normal flour transport or with special equipment Assures that premix is uniformly added to flour Dr. Imran Pasha, NIFSAT, UAF 30
Vital component of wheat flour fortification process Control the level of fortificant or premix required to add in flour Mechanisms of micro feeders in flour mills used today are of three types. Revolving disk Drum type Screw type Dr. Imran Pasha, NIFSAT, UAF 31
Mechanism of Screw type feeders Dr. Imran Pasha, NIFSAT, UAF 32
SCREW FEEDER Control panel Electric motor Gear Box Feeder Screw Hopper DR. IMRAN PASHA, NIFSAT, UAF 33
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To normalize production of mill start it and let it to run for fifteen minutes Set the feeder rate and run it along with the mill Add premix in the hopper of micro feeder and ensure its presence during the process Check the weight of added premix at start of the mill and after every two hours to confirm correct addition rate Dr. Imran Pasha, NIFSAT, UAF 35
During operation of micro feeder ensure the presence of premix in the hopper by visual inspection by a person Before shutting down the mill, stop the micro feeder at the end of process At end of production run turn off feeder before shutting down mill. Maintain the records of following items like: Premix lot number being used Time of activities like sampling and weighing etc. Weights of premix and flour Times of production run start and finish Dr. Imran Pasha, NIFSAT, UAF 36
Ideally national leaders from public, private, and civic sectors work together to establish country standards for fortification. Among factors to consider are: Existing regulations Global and regional recommendations Dietary needs in the population Per capita flour consumption Extraction rate of commonly consumed flour Cost of premix combinations Effect on sensory properties Dr. Imran Pasha, NIFSAT, UAF 37
Understand and follow existing country regulations for food fortification Follow best practices for quality control and quality assurance Participate in national process to develop standards that reflect industry capability Advocate for mandatory legislation Dr. Imran Pasha, NIFSAT, UAF 38
Population has equal access to health benefits from fortified flour, regardless of economic status All millers in country have the same cost expectations Quality assurance is easier to accomplish More than 70 countries have legislation for mandatory wheat flour fortification. See the current map and country list at: http://www.ffinetwork.org/global_progress/i ndex.php Dr. Imran Pasha, NIFSAT, UAF 39
The role of marketing is to ensure acceptance of fortification. Marketing is a joint effort of public, private and civic sector partners. Civic Sector Private Sector Public Sector Dr. Imran Pasha, NIFSAT, UAF 40
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Punjab Pure Food Regulations- 2017 Mandatory Wheat Flour Fortification; According to Punjab Pure Food Regulations- 2017: Fortified Atta means the product obtained by milling or grinding cleaned wheat with addition of one or more fortificants Fortification should have conformed the following standards: - Iron: Folic acid: Zinc: Vitamin B12: Not less than 15 ppm in form of NaFeEDTA Not less than 1 ppm Not less than 30 ppm in form of Zinc Oxide Not less than 0.008 ppm (Cyanocobalamin) Dr. Imran Pasha, NIFSAT, UAF 42
QUALITY degree to which a set of inherent characteristics fulfils requirements The totality of characteristics of a product or service that bear on its ability to satisfy stated and implied needs Quality characteristic Inherent characteristic of a product, process or system related to a requirement Dr. Imran Pasha, NIFSAT, UAF 43
QUALITY ASSURANCE (QA) Proactive Approach A planned and systematic approach of all actions necessary to provide confidence that Technical requirements have been established Products and Process conform to the established technical requirements Satisfactory performance is achieved Out of QA expressed numerically as the results of QC exercise Process Oriented Applies to Feeder, Premix, Process, Packaging, Labelling, Sampling etc Examples Premix is provided by certified supplier with certification of analysis Installing and maintaining a quality feeder Dr. Imran Pasha, NIFSAT, UAF 44
Quality Control (QC) Part of quality management focused on fulfilling quality requirements The operational techniques and activities that sustain a quality of product or service that will satisfy given needs; also the use of such techniques and activities The operational techniques and activities used to requirements for quality Examples Conforming flour is fortified using qualitative tests Micronutrients in allowable range confirmed by quantitative tests Premix usage against production of flour fulfill Dr. Imran Pasha, NIFSAT, UAF 45
Inspection and Quality Control Assess of prescribed and defined quality standards that are being maintained during Services Production Other important relevant activities in whole process e.g. o To check premix quality o To check the quantity of premix in flour through feeder o To check the presence of premix in fortified flour Dr. Imran Pasha, NIFSAT, UAF 46
QC Structure Mill level Availability of Test kits, Ichecks External Laboratories by regulatory bodies Spectrophotometer Monthly sample Third Party Independent laboratory Subsidy on premix linked with quality confirmity Dr. Imran Pasha, NIFSAT, UAF 47
Quality systems GMP (Good Manufacturing practices) HACCP (Hazard Analysis and Critical Control point) ISO 9000, 9001 (quality management system) ISO 14000 (Environmental management System) ISO 22000 (Food safety management system) Dr. Imran Pasha, NIFSAT, UAF 48
MONITORING AND EVALUATION FRAMEWORK REGULATORY MONITORING INTERNAL EXTERNAL COMMERCIAL INDIVIDUAL MONITORING HOUSEHOLD LEVEL IMPACT EVALUATION Dr. Imran Pasha, NIFSAT, UAF 49
Role of Inspectors and Food Safety Officers Ensure compliance against the standards Confirming that technical specifications, process control and quality procedures and records are maintained at the mill and packaging sites Inspecting and verifying legal compliance with standards At least 80% of samples should meet the minimum legal requirements Less than 20% samples may have nutrient content above the maximum level Dr. Imran Pasha, NIFSAT, UAF 50
Check the Storage Place of premix Check the inventory of premix Check the calibration of the micro feeder Check the Quantity of Iron in fortified flour by Iron Spot Test Collect the samples of the fortified flour as per the direction of the food department Send the collected samples of the fortified flour to reference laboratories at least three times in a year Food department laboratories Lahore Bahawalpur Khushab Dr. Imran Pasha, NIFSAT, UAF 51
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