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TRAINING MANUAL 1 PUBLIC SECTOR REGULATORY MONITORING STAFF

TRAINING MANUAL - Global Alliance for Improved Nutrition · TRAINING MANUAL 1 PUBLIC SECTOR REGULATORY MONITORING ... •Adding vitamins and minerals to flour during the milling process

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TRAINING MANUAL

1

PUBLIC SECTOR REGULATORY MONITORING

STAFF

• Wheat (Triticum aestivum) is an imperative food crop

oEnergy

oVital nutrients (up to 60%)

oStaple diet

• In Pakistan, wheat production and average wheat grain yield

is 25.482 million tonnes and 2,752 kg per hectare

(Economic survey of Pakistan, 2015-16)

Wheat Consumption in Pakistan is >300g/day

More than 50% of total energy intake is derived from cereal products

Dr. Imran Pasha, NIFSAT, UAF 2

Maize

22%

Dr. Imran Pasha, NIFSAT, UAF 3

Wheat

21%

Rice

16%

Others

11%

Cereals

70%

8%

4%

7% 6%

3%

Animal & fish

products

Legumes, oilseeds

Roots & tubers Sugar

Other Vegetables &

melons Fruits 2%

Children

Severely Underweight 39%

Stunted Growth 36.8%

Iron Deficiency 66.5%

Vitamin A Deficiency 12.5%

Zinc Deficiency 37%

Severe Iodine Deficiency 23% (NNS, 2011)

RDA of Iron 8-11mg/day

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

Dr. Imran Pasha, NIFSAT, UAF 6

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

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.

milling process, available

9

Loss in the concentration during micronutrients.

Dr. Imran Pasha, NIFSAT, UAF

10 Dr. Imran Pasha, NIFSAT, UAF

(IARP, 2014) (PFMA) 11 Dr. Imran Pasha, NIFSAT, UAF

• Grinding

• Sieving

• Purification

• Flour handling and grading

In the Break System

12 Dr. Imran Pasha, NIFSAT, UAF

• 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

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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

15 Dr. Imran Pasha, NIFSAT, UAF

Foods made with wheat and maize are widely

consumed

Grain milling is a centralized business

with broad distribution of products

Consequently, fortification has the potential to reach millions of people.

Leverage Existing Infrastructure to Reach Population

Dr. Imran Pasha, NIFSAT, UAF 16

Mineral loss at 75-80% extraction

17 Dr. Imran Pasha, NIFSAT, UAF

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

18 Dr. Imran Pasha, NIFSAT, UAF

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.

Photo courtesy of Hexagon Nutrition

19 Dr. Imran Pasha, NIFSAT, UAF

• 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

20 Dr. Imran Pasha, NIFSAT, UAF

Elemental Iron

(reduced iron or electrolytic iron)

21 Dr. Imran Pasha, NIFSAT, UAF

Ferrous Sulfate

Ferrous Fumarate Sodium Iron EDTA (NaFeEDTA)

22

Iron Source Concentration

of Fe (%)

Color Relative

Bioavailability

Ferrous sulfate 32 White 100%

Ferrous fumarate 33 Red 100%

Ferric

orthophosphate

28 Yellow 25-32%

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

• 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.

23 Dr. Imran Pasha, NIFSAT, UAF

Sodium-iron-EDTA for wheat flour enrichment or fortification should be a

24 Dr. Imran Pasha, NIFSAT, UAF

USP/FCC grade. It is a brownish yellow powder

• Assay • EDTA • Fe (III)

• pH (1%)

• Water-insoluble matter

• Chloride

• Sulfate

• Arsenic

• Lead

66.0-71.0% 12.5-14.0%

3.5-5.5

0.1% Max.

0.05% Max.

0.2% Max.

0.0003% Max.

0.001% Max.

Source: Dr. Paul Lohmann Chemicals, Germany

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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

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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

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.

27 Dr. Imran Pasha, NIFSAT, UAF

• Premix is continuously added to

the flour stream using a feeder

• Premix addition is proportional to

the rate of flour production

• Validation of mixing uniformity is

required

Premix can be continuously added into a collection

conveyor such as the one shown here.

28 Dr. Imran Pasha, NIFSAT, UAF

conveyor

feeder

• 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

Batch mixer photo courtesy of

Buhler Company 29 Dr. Imran Pasha, NIFSAT, UAF

Premix Feeder

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• Measures correct amount of

premix

• Position at appropriate

place in production line

Mixing Mechanism

• Can be done during normal

flour transport or with

special equipment

• Assures that premix is

uniformly added to flour

• 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

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Control panel

Electric motor

Gear Box

Feeder Screw

Hopper

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SCREW FEEDER

DR. IMRAN PASHA, NIFSAT, UAF

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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

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Ideally national leaders from public, private, and civic sectors work together to

establish country standards for fortification. Among factors to consider are:

Dr. Imran Pasha, NIFSAT, UAF 37

• 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

• 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.

Private

Sector

Dr. Imran Pasha, NIFSAT, UAF 40

Public

Sector

Civic

Sector

Dr. Imran Pasha, NIFSAT, UAF

41

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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)

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

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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 45

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

fulfill • 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

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

Dr. Imran Pasha, NIFSAT, UAF 47

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

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)

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Dr. Imran Pasha, NIFSAT, UAF 49

MONITORING AND EVALUATION FRAMEWORK REGULATORY MONITORING

•INTERNAL

•EXTERNAL

•COMMERCIAL

INDIVIDUAL MONITORING

•HOUSEHOLD LEVEL

•IMPACT EVALUATION

Dr. Imran Pasha, NIFSAT, UAF 50

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

• 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

Dr. Imran Pasha, NIFSAT, UAF 51

• Food department laboratories

Lahore Bahawalpur Khushab

52 Dr. Imran Pasha, NIFSAT, UAF

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