status of nutrition labelling…. - ilsi...

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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….

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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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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*


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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*


lcFOS is bifidogenic*


lcFOS helps increase intestinal bifidobacteria and helps maintain a good

intestinal environment*


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


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 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)


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


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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)


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



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)


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PROPOSED AMENDMENT



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


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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

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PROMOTING THE UNDERSTAND OF NUTRITION ING THE UNDERSTAND OF NU

LABELLING AND CLAIMSLABELABE AND CLAIMSAND CLAIMS

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+603 – 8885 0797

+603 – 8885 0790

[email protected]

http://fsq.moh.gov.my

hppt://www.facebook.com/bkkmhq

http://twitter.com/bkkmputrajaya

CONTACT

Thank you for you attention

status of nutrition labelling…. - ilsi...

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