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Updates on Nutrition Labeling and Updates on Nutrition Labeling and
Claims Regulations in Malaysia
Norrani EksanFood Safety and Quality Division
Ministry of Health Malaysia
ILSI Seminar, Manila, PhilippinesAugust 4, 2015
Outline of presentation
• Status of nutrition labelling and claims
ØNutrition labelling
ØConditions for nutrition claims
• Procedure for approval of nutrition
claim
• Proposed amendment
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• Malaysia- mandatory nutrition labelling for wide
variety of foods
• Law gazzeted in 2003 and enforced in 2005
• More than 50 categories of commonly
consumed foods
STATUS OF NUTRITION LABELLING….
5
2 parts:
Declaration of energy value, carbohydrate, protein and fat
Specific provisions for claims such as nutrient content claim, nutrient function
claim and nutrient comparative claim
Nutrition n Labellingg and Claims in Malaysia
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Nutrition labelling only mandatory for certain food group.
but……….
When a food makes a nutrition claim, it is mandatory to include a nutrition labelingand the amount of any other nutrient for
which a nutrition claim is made in respect of the food.
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FOODS REQUIRING NUTRITION LABELLING
Foods that make nutrition
claim
Foods that are frequently
consumed and in significant amounts, and
are important to the community
Food that have been fortified,
enriched, vitaminised,
supplemented or strengthened
with specific vitamins and
minerals
Special purpose foods:
• Infant formula
• Follow-up formula
• Canned baby food & cereal based food for infants and young children
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Categories of
Foods That
Require
Mandatory
Nutrition
Labelling
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• Must declare –
– Energy
– Protein
– Carbohydrate
– Fat
– (Total sugars – only for ready to drink
beverages)
LABELLING OF MANDATAORY NUTRIENTS LABELLING OF MANDATAORY NUTRIENTS
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Liquid
Food
§ Energy
§ Carbohydrate, Protein, Fat
§ Total Sugars (Ready to drink beverage)
Solid
Food§ Energy
§ Carbohydrate, Protein, Fat
Single
Portion
§ Column for nutrient listing
§ Column for per package/per serving
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Vitamins and Minerals
Only those listed in the NRV
Others à must have prior written approval of
the ‘Director’
Must be present 5% of NRV per serving
Other Nutrients
Dietary Fibre
Cholesterol
Sodium
Fatty Acids
Where a claim is made à all 4 main types of FA shall be declared
Recommended Format:
Fat ..... g
comprising of
Monounsaturated Fatty Acid ..... g
Polyunsaturated Fatty Acid ..... g
Saturated Fatty Acid ..... g
Trans Fatty Acid ..... g
LABELLING OF OPTIONAL NUTRIENTS
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Permitted Claims*
Nutrient content claim
Nutrient comparative claim
Nutrient function claim
Other function claim
Nutrient enrichment or fortification claim
“Nutritious” Claim
Prohibited Claims
Disease risk reduction claim
Prevent, alleviate, treat or cure disease, disorder or other
physiological function
Provide an adequate source of all essential nutrients
Doubt the safety of similar food.
Arouse or exploit fear in consumer
Cannot be substantiated
itt d Cl i * P hibit d Cl
CLAIMS ON FOOD LABELS
* Must meet condition required for making claims
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HEALTH CLAIMSHEALTH CLAIMS
(disease risk reduction claim)
Example that is Prohibited in Malaysia
EXAMPLS OF OTHER EXAMPLS OF O
PROHIBITED
OTHER OF O
D D CLAIMS
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FUNCTION CLAIM
• Describe the specific role ofthe nutrient in relation tophysiological functions
• Ex: Iron is a factor in redblood cell formation.
• Calcium aids in the dev ofstrong bones and teeth
HEALTH CLAIM
• Suggest or implies arelationship between a foodand health condition
• Health claim such as diseaserisk reduction claims are notpermitted
• Ex: Iron can help reduce therisk of anemia
FUNCTION CLAIM VS HEALTH CLAIM
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NUTRITION CLAIMS
1. Nutrient content claim
2. Nutrient comparative claim
3. Nutrient function claim
4. Claim for enrichment, fortification or other
words of similar meaning
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CONDITIONS : NUTRIENT CONTENT CLAIMS NUTRIENT CONTENT CLAIM
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CONDITIONS : NUTRIENT CONTENT CLAIMSNUTRIENT CONTENT CLAIM
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CONDITIONS : NUTRIENT COMPARATIVE CLAIMS
A product that has new formulation with REDUCED or EXTRAnutrient level
The food being compared should be different versions of the same food or similar food
eg. Cheese A (old formulation vs Cheese B (new formulation)
Identified as a percentage, fraction or absolute amount
eg. 50% less fat, 5g more protein or ½ reduced sodium
Energy / nutrient content between compared foods must differ by at least 25%. Micronutrient à at least 10%
Minimum absolute difference in the energy value or nutrient content (≥ the value required for claim as “source” or “low”)
NUTRIENT COMPARATIVE CLAIM
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NUTRIENT FUNCTION CLAIM &NUTRIENT FUNCTION CLAIM &
OTHER FUNCTION CLAIM
~ Malaysia adopts a “positive list” approch
~ Include “classical nutrient” and “other food component”
~ Only claims on this list are permitted [Reg.18E(14)]
~ Total of 52 function claims permitted
♦ 23 function claims for “classical nutrient” such as:
• Protein
• 9 Vitamins (A, B1, B2, B12, C, D, E, Folate, Niacin)
• 5 Minerals (Ca, Fe, I, Mg, Zn)
♦ 29 other function claims for “other food components” such
as:
• Lutein, Beta-glucan, Plant Sterol etc.
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NUTRIENT FUNCTION CLAIM UTRIENT FUNCTION CLAIM“CLASSICAL NUTRIENTS”
Nutrient Claim
Calcium Calcium aids in the development of strong bones and teeth
Folic acid Folic acid is essential for growth and division of cells
Folate plays a role in a formation of red blood cells
Folate helps to maintain the growth and developmental of the foetus
Iron Iron is a factor in red blood cell formation
Iron is a component of haemoglobin in red blood cell which carries oxygen to all parts of
the body
Iodine Iodine is essential for the formation of thyroid hormone
Magnesium Magnesium promotes calcium absorption and retention
Niacin Niacin is needed for the release of energy from protein, fats and carbohydrate
Protein Protein helps build and repair body tissues
Protein is essential for growth and development
Protein provides amino acids necessary for protein synthesis
Gazetted PU(A) 88/2003
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NUTRIENT FUNCTION CLAIM
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NUTRIENT FUNCTION CLAIM
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NUTRIENT FUNCTION CLAIM UTRIENT FUNCTION CLAIM“CLASSICAL NUTRIENTS”
Nutrient Claim
Vitamin A Vitamin A aids is maintaining the health of skin and mucous membrane
Vitamin A is essential for the functioning of the eyes
Vitamin
B1/Thiamine
Vitamin B1/Thiamine is needed for the release of energy from carbohydrate
Vitamin B2/
Riboflavin
Vitamin B2/ Riboflavin is needed for the release of energy from protein, fats and
carbohydrate
Vitamin B12/
Cyanocobalamine
Vitamin B12/ Cyanocobalamine is needed for red blood cell production
Vitamin C Vitamin C enhances absorption of iron from non-meat source
Vitamin C contributes to the absorption of iron from food
Vitamin D Vitamin D helps the body utilize calcium and phosphorus
Vitamin D is necessary for the absorption and utilization of calcium, and
phosphorus
Vitamin E Vitamin E protects the fat in body tissues from oxidation
Zinc Zinc is essential for growth protects the fat in body tissues from oxidation
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OTHER FUNCTION CLAIM OTHER FUNCTION CLAIM “OTHER FOOD COMPONENTS”
Nutrient Claim
Beta glucan Beta glucan from (oat soluble fibre) helps lower or reduce cholesterol*
Inulin and
oligofructose
(fructo-
oligosaccharide)
Inulin helps increase intestinal bifidobacteria and helps maintain a good
intestinal environment*
Oligofructose (fructo-oligosaccharide) helps increase intestinal bifidobacteria
and helps maintain a good intestinal environment*
Inulin is bifidogenic*
Oligofructose (fructo-oligosaccharide) is bifidogenic*
Inulin is prebiotic* (2009)
Oligofructose (fructo-oligosaccharide) is prebiotic *
(2009)
Plant sterol / plant
stanol
Plant sterol / plant stanol helps lower or reduce cholesterol*
Sialic acid Sialic acid is an important component of brain tissues*
Gazetted : P.U.(A) 88/2003 & P.U.(A) 306/2009
* Specific condition required
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OTHER FUNCTION CLAIM OTHER FUNCTION CLAIM “OTHER FOOD COMPONENTS”
Nutrient Claim
Beta glucan Beta glucan from (barley) helps lower or reduce cholesterol*
Bifidobacterium
lactis
Bifidobacterium lactis helps improve a beneficial intestinal microflora*
Bifidobacterium lactis may help to reduce the incidence of diarrhea*
DHA and ARA DHA and ARA may contribute to the visual development of infant*
HAMRS High Amylose Maize Resistant Starch (HAMRS) helps improve / promote
colonic/bowel/intestinal function/ environment*
Isomaltulose Isomaltulose is slowly hydrolysed to glucose and fructose, and therefore it
provides longer lasting energy compared to sucrose*
Isomaltulose is a slowly released source of energy compared to sucrose*
Isomaltulose provides longer lasting energy compared to sucrose*
Isomaltulose is slowly hydrolysed to glucose and fructose, compared with
sucrose*
Lutein As a predominant macular pigment in the retina, Lutein is able to filter blue
light and may protect the eye*
* Specific condition required
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OTHER FUNCTION CLAIM OTHER FUNCTION CLAIM “OTHER FOOD COMPONENTS”
Nutrient Claim
Oat soluble fibre
(beta- glucan)
Oat soluble fibre (beta- glucan) helps to lower the rise of blood glucose
provided it is not consumed together with other food*
Oligosaccharide
mixture containing
90%(wt/wt) GOS
and 10% (wt/wt)
lcFOS
Oligosaccharide mixture containing 90%(wt/wt) GOS and 10% (wt/wt)
lcFOS is prebiotic*
Oligosaccharide mixture containing 90%(wt/wt) GOS and 10% (wt/wt)
lcFOS is bifidogenic*
Oligosaccharide mixture containing 90%(wt/wt) GOS and 10% (wt/wt)
lcFOS helps increase intestinal bifidobacteria and helps maintain a good
intestinal environment*
Oligosaccharide mixture containing 90%(wt/wt) GOS and 10% (wt/wt)
lcFOS helps to improve the gut/ intestinal immune system of babies /
infant*
Oligofructose-
inulin mixture
Oligofructose-inulin mixture containing containing shorter chain inulin
(oligofructose DP 3-9) and longer chain inulin (inulin DP ≥10) in a 50:50
ratio ± 10% each helps to increase calcium absorption and increase
bone mineral density when taken with calcium rich food*
* Specific condition required32
OTHER FUNCTION CLAIM OTHER FUNCTION CLAIM “OTHER FOOD COMPONENTS”
Nutrient Claim
Patented
cooking oil blend
Patented cooking oil blend helps to increase HDL Cholesterol
and improve HDL/LDL cholesterol ratio*
Plant sterol ester Plant sterol ester helps lower or reduce cholesterol*
Polydextrose Polydextrose is bifidogenic*
Polydextrose helps increase intestinal bifidobacteria and helps
maintain a good intestinal microflora*
Resistant dextrin
/ Resistant
maltodextrin
Resistant dextrin / Resistant maltodextrin is a soluble dietary
fibre that helps to regulate / promote regular bowel movement
especially of people with a tendency to constipation*
Soy protein Soy protein helps to reduce cholesterol*
* Specific condition required
Specific conditions required for “other function claim”
Ø Minimum amount of the relevant “food component” that must be
present
ØAdditional labelling requirements, if relevant
ØRestriction to selected foods, if relevant
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Specific conditions required for “other function claim”
Ø Mini nt f th le nt “food nt” that t be
CONDITIONS : OTHER FUNCTION CLAIM
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GUIDE TO NUTRITION LABELLING AND CLAIMS
ü Updates on Nutrition
Labelling & Claims
Regulations
üTo assist industry and
enforcement officers
understand the regulation
üWebsite
http://fsq.moh.gov.my/v4
PROCEDURE FOR APPROVAL OF NUTRITION R APPROVA
CLAIMSAccompany by supporting document :
• Proposed claim and food
• limit of probable daily intake of nutrient
• Chemical structure and formula of the nutrient
• Information on physiological role of the nutrient
• Level of “source: of nutrient per 100g or ml with scientific justification of the proposed level.
• Evidence or benefit from 5 clinical trial (Studies should be published in refered journal
• Epidemiological and experimental studies and reviewed paper may be included as supportive evidence.
• Information regarding stability and bioavailability of the nutrient in raw, processed and/or finished food
• Analytical method
• Data on safety evaluation derived both chronic and acute studiesc
• Approval from other country)
AMENDMENT PROCESS
STEP ISecretariat will present proposal to regulate or amend to related Expert Working Group
STEP IIConsultation with industry and stakeholders involved
STEP IIIFood Regulations 1985 Advisory Committee will deliberate the proposal from the expert working
group
STEP IVProposed amendment draft will be published for public consultation
STEP VThe draft amendment for gazattement will be prepared after comments
STEP VIDraft regulation will be forwarded to the legal advisor of Ministry of Health, Attorney General
Chambers for approval and to the Minister of Health for signature
STEP VIIRegulations gazetted and printed
q In additional, nutrition information SHALL be expressed as a % of NRV
q Based on energy needs = 2000 kcal
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PROPOSED AMENDMENT
1. Nutrition Labelling
Additional information on % NRV
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PROPOSED AMENDMENT2. Nutrition Labelling
Expand the NRV List
Nutrient Unit Existing Amendment
Energy kcal 2000
Protein g 50
Carbohydrate g 300
Fat g 66.7
Vitamin A µg 800
Vitamin D µg 5
Vitamin C mg 60
Vitamin E mg 10
Vitamin K µg 60
Thiamine mg 1.4 1.2
Riboflavin mg 1.6 1.2
Niacin mg 18 15
Vitamin B6 mg 2 1.3
Vitamin B12 µg 1 2.4
Calcium mg 800 1000
Magnesium mg 300
Iron mg 14
Zinc mg 15
Iodine µg 150
Choline mg 550
Folic Acid µg DFE 400
Biotin µg 30
Pantothenate mg 5
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PROPOSED AMENDMENT
3. Related to Permitted Claims
Definition of “Other Function Claim”
• a claim which provides a positive contribution to health or to the improvement of a function or to modifying or preserving health by a food or other component.
Claim related to Malaysian Dietary Guidelines
• Only key messages or any other words of the same significance that are specified in the current Malaysian Dietary Guidelines (MDG)
Subject to official approval and gazettement process
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KEY MESSAGES1. Eat a variety of foods within your recommended intake
2. Maintain body weight in a healthy range
3. Be physically active everyday
4. Eat adequate amount of rice, other cereal products
(preferably whole grain) and tubes
5. Eat plenty of fruits and vegetables everyday
6. Consume moderate amounts of fish, meat, poultry, egg,
legumes and nuts
7. Consume adequate amounts of milk and milk products
8. Limit intake of foods high in fats and minimise fats and oils
in food preparation
9. Choose and prepare foods with less salt and sauces
10. Consume foods and beverages low in sugar
11. Drink plenty of water daily
12. Practise exclusive breastfeeding from birth until six months
and continue to breastfeed until two years of age
13. Consume safe and clean foods and beverages
14. Make effective use of nutrition information on food labels
* These claims are only permitted if the total of SFAs and TFAs is not
more than 28% of the total fatty acids content of the food
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PROPOSED AMENDMENT
4. Condition for Nutrient Content
Claim (New Components)
Component Claim Not Less Than
Omega 3 Source * 0.3g per 100g
High * 0.6g per 100g
Component Claim Not MoreThan
Gluten Free 0.002g per 100g (solids or liquids)
Subject to official approval and gazettement process
ØFood consisting of one or more ingredients from wheat (all
Triticum species) which have been specially processed to reduce
the gluten content
ØLevel of gluten content in total : 0.002g – 0.01g per 100g
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PROPOSED AMENDMENT
5. Nutrient Comparative Claim
Reduced
Gluten
Subject to official approval and gazettement process
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PROPOSED AMENDMENT *6. Other Function Claims
(New Components)
Component Claim Specific Condition
D-Ribose helps to promote
energy recovery
during or after
physical activities
- Min amount: 3g per serving
- Formula dietary foods
- Additional labelling requirements “Do not
exceed 2 servings per day”
Calcium 3-hydroxy-
3-methyl butyrate
monohydrate
(CaHMB)
a) help to regain
strength
b) supports tissue
building
- Min amount: 1.5g per serving
- Formula dietary foods
- Additional labelling requirements
a) Not recommended for pregnant women
and a person under the age of eighteen
years
b) The number of recommended servings
per day; and
c) Take only on health professional adviceǁ
on the principal display panel
* Subject to official approval and gazettement process 44
PROPOSED AMENDMENT
7. Other Function Claims
(Minimum Amount Required – Revised)
Subject to official approval and gazettement process
Component : Inulin
Existing Regulation – PU(A) 306/2009 2g per serving
Director’s written approval (2009) 1.25g per serving
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PROPOSED AMENDMENT
8. Other Function Claims
(Minimum Amount Required – Revised)
Existing Regulation – PU(A) 306/2009
(Plant sterol / plant stanol )
1.3g per 100g (solids)
160mg per 100ml (liquids)
Component : Plant sterol / plant stanol / plant sterol 0.65g per serving
Director’s written approval (2010)0.4g per serving
(in a “free basis” form)
Subject to official approval and gazettement process
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PROPOSED AMENDMENT
9. Other Function Claims
(Minimum Amount Required – Revised)
Component : Oligofructose-inulin mixture
Director’s written approval (2008)
Oligofructose-inulin mixture containing 36-42%
oligofructose (DP 2-10) and 50-56 % inulin (DP
>10) helps to increase calcium absorption and
increase bone mineral density when taken with
calcium rich food
Revised
Oligofructose-inulin mixture containing shorter
chain inulin (oligofructose DP 3-9) and
longer chain inulin (inulin DP ≥ 10) in a 50 :
50 ratio ± 10 % each helps to increase calcium
absorption and increase bone mineral density
when taken with calcium rich foodSubject to official approval and gazettement process
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PROPOSED AMENDMENT *
Component Claim Specific Condition
Beta palmitin i. Beta palmitin contributes to increased
calcium absorption
ii. Beta palmitin contributes to increased
fat absorption
(i) >18% C16:0 content based on
total fatty acids
(ii) > 40% C16:0 in sn-2 position
based on total C16:0
content
Mixture containing 50%
(weight over weight)
Galactooligosaccharide
(GOS) and 50% (weight
over weight)
Polydextrose (PDX)
i. Mixture containing 50% (weight over
weight) Galactooligosaccharide
(GOS) and 50% (weight over weight)
Polydextrose (PDX) is prebiotic
ii. Mixture containing 50% (weight over
weight) Galactooligosaccharide
(GOS) and 50% (weight over weight)
Polydextrose (PDX) is bifidogenic“;
- Claim only permitted for infant
formula and follow-up formula.
- 0.4g/100ml (0.2g/100ml GOS, 0.2
g/100ml PDX)
DD AAAAAPROPOSEDPPRROOPPOOSSEEDDxx. Other Function Claims
(New Components)
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PROPOSED AMENDMENTxx. Maximum amount for Vitamins & Minerals
No. Nutrient Maximum amount in recommended daily serving
Amendment Existing
1 Vitamin B6 93 mg 4 mg
2 Vitamin C 1750 mg 100 mg
3 Vitamin D 35 μg 800 I.U (20 μg)
4 Vitamin E 970 mg 50 I.U (50 mg)
5 Nicotinamide 820 mg -
6 Molybdenum 350 μg -
7 Phosphorus 1250 mg 1.4 g
8 Selenium 200 μg -
9 Magnesium 250 mg -
10 Folic Acid 600 μg 400 μg
11 Vitamin A 1000 μg 5000 I.U (1500 μg)
12 Calcium 1500 mg 1.4 g
13 Copper 2 mg -
14 Flouride 3.5 mg -
15 Iodine 200 μg 200 μg
16 Iron 20 mg 20 mg
17 Manganese 2 mg -
18 Zinc 15 mg -
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PROPOSED AMENDMENTxx. Claims Related to Nutrient Addition
Permitted Claims Nutrient Condition
‘Enriched’, ‘Fortified’,
‘Strengthened’ or
‘Enhanced’ any other words
of similar meaning
Vitamins and MineralsMeet minimum level for claim 'high in' in Table II, Fifth A Schedule
Amino acids & Fatty Acids Meet minimum level for claim 'high in' in Table II, Fifth A Schedule
Other Food Components Meet minimum level for function claims in Table III, Fifth A Schedule
‘Contain’, ‘Added’, ‘With’, or
any other words of similar
meaning
Vitamins and Minerals
Meet minimum level for claim
'source of' in Table II, Fifth A Schedule
Amino Acids & Fatty Acids
Meet minimum level for claim
'source of' in Table II, Fifth A Schedule
Other Food Components Meet minimum level for function claims in Table III, Fifth A Schedule
Naturally Occurring NutrientMeet minimum level for label declaration
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PROPOSED AMENDMENT
xx. Claims Related to Nutrient Addition (con’t)
Conditions for Declaration of Naturally
Occurring Nutrient
Component Minimum Amount Required
Ganglioside 11mg / 100g
Subject to official approval and gazettement process
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FRONT OF PACK LABELLING
Objective
Ø give a quick picture about calorie
content in a product
Ø to allow consumer to plan and control
the daily energy intake as needed,
especially high-calorie foods
Ø Based on 2000kcal52
Why based on 2000kcal?
Ø 2000 calories is based
on daily average of
energy requirement of
a normal adult
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PROMOTING THE UNDERSTAND AND USE OF ROMOTING THE UNDERSTAND AND USE O
NUTRITION LABELLING AND CLAIMSNUTRITION LNUTRITION L D CLAIMS
Nutrition Information Centre
54
PROMOTING THE UNDERSTAND OF NUTRITION ING THE UNDERSTAND OF NU
LABELLING AND CLAIMSLABELABE AND CLAIMSAND CLAIMS
55
+603 – 8885 0797
+603 – 8885 0790
norrani@moh.gov.my
http://fsq.moh.gov.my
hppt://www.facebook.com/bkkmhq
http://twitter.com/bkkmputrajaya
CONTACT
Thank you for you attention
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