REGULATORY UPDATES IN MALAYSIA Norrani Eksan Food Safety and - - PowerPoint PPT Presentation

NUTRITION LABELLING AND CLAIMS: REGULATORY UPDATES IN MALAYSIA

Norrani Eksan Food Safety and Quality Division Ministry of Health Malaysia

NSM Pre-Conference Symposium Hotel Istana, KL 24 – 26 July 2018

OUTLINE OF THE PRESENTATION

Current Status of Nutrition Claims Update on Amendment of Regulation Procedure for Approval of Nutrition Claims Food and Nutrition Labelling: Consumer Perception

Nutrition Labelling and Claims in Malaysia

• Nutrient declaration
• Energy Value
• Carbohydrate
• Protein
• Fat

+ Total sugars

Specific provisions for claims;

• Nutrient content claim
• Nutrient function claim
• Nutrient comparative claim

Nutrition labelling only mandatory for certain food group.

but ….

When a food makes a nutrition claim, it is mandatory to include a nutrition labeling and the amount of any other nutrient for which a nutrition claim is made in respect of the food.

PERMITTED NUTRITION CLAIMS

• Describe the level of a nutrient

contained in a food

Nutrient content claim [Regulation 18C]

• Claim that compares the nutrient levels
• r energy value of 2 or more product

Nutrient comparative claim [Regulation 18D]

• Describe the level of a

nutrient contained in a food

Claim for enrichment, fortification [Regulation 26]

• Describe the physiological role of the

nutrient in the growth, development & normal functions of the body

Nutrient function claim [Regulation 18E]

REG.18C ~ NUTRIENT CONTENT CLAIM

“Low in” or “Free of”

• Nutrients that are supposedly bad for

health, when consumed in excessive amounts.

“Source of” or “High in”

• Nutrients that are supposedly

beneficial to health

CONDITIONS FOR NUTRIENT CONTENT CLAIMS “LOW IN” OR “FREE OF”

COMPONENT CLAIM NOT MORE THAN Energy Low 40 kcal (170 kJ) per 100 g (solid) or 20 kcal (80kJ) per 100 ml (liquids) Free 4 kcal per 100 g (atau 100 ml) Fat Low 3 g per 100 g (solid) or 1.5 per 100 ml (liquids) Free 0.15 g per 100 g (or 100 ml) Saturated fat Low 1.5 g per 100 g (solid) or 0.75 g per 100 ml (liquids) and 10% of total energy of the food Free 0.1 g per 100 g (solids) or 0.1 g per 100 ml (liquids)

CONDITIONS FOR NUTRIENT CONTENT CLAIMS “LOW IN” OR “FREE OF”

COMPONENT CLAIM NOT MORE THAN Cholesterol Low 0.02 g per 100 g (solids) or 0.01 g per 100 ml (liquids) Free 0.005 g per 100 g (solids) or 0.005 g per 100 ml (liquids) Trans Fatty Acids Low 1.5 g per 100 g (solids) or 0.75 g per 100 ml (liquids) and 10% of total energy of the food Free 0.1 g per 100 g (solids) or 0.1 g per 100 ml (liquids)

CONDITIONS FOR NUTRIENT CONTENT CLAIMS “LOW IN” OR “FREE OF”

COMPONENT CLAIM NOT MORE THAN Sugars Low 5 g per 100 g (solid) or 2.5g per 100 ml (liquid) Free 0.5 g per 100 g (solid) or 0.5 g per 100 ml (liquid) Sodium Low 0.12 g per 100 g(solid) or 0.06 g per 100 ml (liquid) Very low 0.04 g per 100 g(solid) or 0.02 g per 100 ml (liquid) Free 0.005 g per 100 g(solid) or 0.005 g per 100 ml (liquid)

Trans Fatty Acids Free 0.1 g per 100 g (solids) or 0.1 g per 100 ml (liquids)

COMPONENT CLAIM NOT MORE THAN

COMPONENT CLAIM NOT MORE THAN

Cholesterol Free 0.005 g per 100 g (solids) or 0.005 g per 100 ml (liquids)

NUTRIENT CONTENT CLAIM

CONDITIONS FOR NUTRIENT CONTENT CLAIMS “SOURCE OF” OR “HIGH IN”

COMPONENT CLAIM NOT LESS THAN Protein Source 10% of NRV per 100 g (solids) or 5% of NRV per 100 ml (liquids) or 5% of NRV per 100 kcal High (at least 2 times the value for “source of ”) Vitamins and minerals Source 15% of NRV per 100 g (solids) or 7.5% of NRV per 100 ml (liquids) or 5% of NRV per 100 kcal High (at least 2 times the values for “source

• f”)

Dietary Fibre Source 3 g per 100 g (solid) or 1.5 g per 100 ml (liquid) High 6 g per 100 g (solid) or 3 g per 100 ml (liquid)

Reduced, less than, fewer , light

A product that has a new formulation with lower or reduced nutrient level

Increased, more than extra

A product that has a new formulation with increased or extra nutrient level

NUTRIENT COMPARATIVE CLAIMS

NUTRIENT COMPARATIVE CLAIM CRITERIA

The food being compared should be different versions of the same food or similar food. The foods being compared should be clearly identified. The full details of the comparison should be given (e.g units, quantity). The difference in amounts of the energy or nutrient content should be identified as a percentage, fraction or absolute amount. Energy or nutrient content between compared foods must differ by at least 25%. Micronutrient content between compared foods must differ by at least 10% (eg. Vitamins & Minerals) The absolute difference in energy or nutrient content must meet the criteria for making a claim for “low in” or “source of”

This eggs have lower cholesterol level (112mg / 2 pcs) as compared to regular eggs 432mg / 2 pcs

Nutrient content between compared foods must differ by at least 25%

To claim this product is less in cholesterol, below is the criteria;

Less in cholesterol

NUTRIENT COMPARATIVE CLAIM

NUTRIENT COMPARATIVE CLAIM

To claim this product is less in sugar, below is the criteria;

Nutrient content between compared foods must differ by at least 25%

‘Less in sugar’

NUTRIENT COMPARATIVE CLAIM

PER.18E ~ 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 ( 31 nutrients/food components) ♦ 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.

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

NUTRIENT FUNCTION CLAIM

“CLASSICAL NUTRIENTS”

OTHER FUNCTION CLAIM

“OTHER FOOD COMPONENTS”

Nutrient Claim Beta glucan Beta glucan from (state the source-oat/barley) helps lower or reduce cholesterol* Inulin and

• ligofructose (fructo-
• ligosaccharide)

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*

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*

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*

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*

NUTRIENT FUNCTION CLAIM

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TABLE I, TWELFTH SCHEDULE UPDATES ON NUTRITION LABELLING

Permitted added nutrient (343 )

• Vitamin and Mineral
• Vit K1 , Vit K2
• Amino Acids
• Fatty Acids
• Nucleotides
• Other food component
• Epigallocatechin gallate (EGCG)
• -Dietary Fibre

26

• Reg. 26

UPDATES ON NUTRITION LABELLING

(3A) There shall be written in the label on a package of food containing Epigallocatechin gallate (EGCG), the words “NOT RECOMMENDED FOR PREGNANT AND LACTATING MOTHER”

* Gazetted in 31st March 2017

27

• Reg. 26

UPDATES ON NUTRITION LABELLING

(11) There shall be written in the label on a package of food other than infant formula, follow-up formula and formulated milk powder for children containing vitamin K, the words “CONTAINS VITAMIN K, PERSONS TAKING WARFARIN SHALL SEEK MEDICAL ADVICE BEFORE CONSUMING THIS PRODUCT”.

• Claims stating that any particular food will provide an

adequate source of all essential nutrients

• Claims implying that a balanced diet or a combination
• f a variety of foods cannot supply adequate amounts
• f all nutrients
• Claims that cannot be substantiated
• Claims suggesting that a food can prevent, alleviate,

treat or cure a disease, disorder or other physiological function

• Claims that cause consumer to doubt the safety of

similar food

• Claims that arouse or exploit fear in consumer

PROHIBITED CLAIMS

PROPOSED AMENDMENT…

Table V - Condition for claim related for added nutrient

PROPOSED AMENDMENT…

Permitted Claims Nutrient Conditions ‘enriched’, fortified, strengthened, enhanced or any

• ther words of

similar meaning vitamin and mineral

• Other food

components Meet minimum level for claim ‘high in’ in fifth Sch

• Meet minimum level for
• ther function claims in Fifth

A Sch ‘contain, added, with, or other words of similar meaning Vitamin and mineral

• Other food

components Meet minimum level for claim ‘source of’ in Fifth Sch

• Meet minimum level for
• ther function claims in Fifth

Sch

• Claims “No added sugars”
• Criteria:
• no sugars of any type have been added to the food.
• the food contains no ingredients that contain sugars as

an ingredient;

• the food contains no ingredients containing sugars that

substitute for added sugars; and

• the sugars content of the food itself has not been

increased above the amount contributed by the ingredients by some other means.

PROPOSED AMENDMENT…

• Reg 18A
• Claim “ No added salt”
• Criteria:
• The food contains no added sodium salts
• The food contains no ingredients that contain

added sodium salts; and

• The ingredients that contain sodium salt that

function as substitute for added salts are not used in the food. PROPOSED AMENDMENT…

New content claim & conditions – Table 1 PROPOSED AMENDMENT…

Component Claim Conditions (not more than) Gluten

Reduced Free

0.01 per 100 g (solid or liquid)

0.002g per 100g ( solid or liquid)

The claim of ‘reduced gluten’ is

• nly permitted in food consisting
• f one or more ingredients from

wheat, rye, barley, oats or their crossbred varieties, which have been specially processed to reduce the gluten content”

New content claim & conditions –

PROPOSED AMENDMENT…

Component Claim Conditions (Not less than) Omega 3 (alpha-linolic acid) Source High 0.3 g per 100g 0.6g per 100g This claim is only permitted if the total of saturated fatty acids and trans fatty acids is not more than 28 percent of the total fatty acids content of the food Ganglioside Source 11 mg per 100g This claim is only permitted in milk and milk products with naturally

• ccurring ganglioside

35

• 3. Related to Permitted Claims

Reg 18F. Definition of “Other Function Claim”

• a claim that describes specific beneficial effect of
• ther food component in food that gives :
• a) positive contribution to health or
• b) improvement of a function of the body

PROPOSED AMENDMENT…

Table III Condition for Other Function Claims

PROPOSED AMENDMENT…

Component Claims Minimum amount required Condition Calcium 3- hydroxy-3- methyl butyrate monohydrate (CaHMB) (i) CaHMB helps to regain strength (ii) CaHMB supports tissue building 1.5 g per serv This claim is only permitted in formula dietary foods Galactooligos accaride(GOS) and polydextrose (PDX) mixture GOS and PDX mixture is a prebiotic GOS and PDX mixture is a bifidogenic 0.4 g per 100ml (0.2g per 100ml) GOS and 0.2g per 100ml PDX Mixture containing 50 per cent (weight over weight) GOS and 50 percent (weight over weight ) PDX These claims are only permitted in infant formula and follow up formula.

Table III Condition for Other Function Claims

PROPOSED AMENDMENT…

Component Claims Minimum amount required Condition D-ribose D-ribose helps to promote energy recovery during or after physical activities 3 g perserving This claim is only permitted in formula dietary food There shall be written on the label the following statement: “ Do not exceed 2 servings per day”

Table III Condition for Other Function Claims

PROPOSED AMENDMENT…

Component Claims Minimum amount required Condition Slowly digestible starch (SDS)

A food containing slowly digestable starch (SDS), consumed as part of the normal first meal of the day, releases carbohydrates gradually and provides energy throughout the morning At least 40%

• f the

available starch must be present as slowly disgestible starch (SDS Claim only permitted for SDS from starch naturally occurring in starchy foods where available carbohydrates provide at least 55 % of the total energy and where at least 55 % of the available carbohydrates is available starch

• Application from industry
• Review and recommendation by Expert

Committee on Nutrition and Health Claim

• Endorsed

by Technical and Advisory Committee on Food regulations 1985

• Approval by Director (DDG)

Procedure for approval of Nutrition Claims

• Accompany 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.

• Sound scientific evidence for the claim. All available

literature including both positive and negative findings on the proposed claim must be provided.

• Data from human intervention trials are preferred

Procedure for approval of Nutrition Claims

• Epidemiological and experimental studies and reviewed

paper may be included as supportive evidence.

• Studies

should include those conducted by

• ther
• rganizations or institutions
• Results of all these studies should be published in referred

journals

• 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

studies

• Approval from other country

Procedure for approval of Nutrition Claims

AMENDMENT PROCESS

• Food and nutrition labelling has been

recognized as one of the strategies to encourage people to adopt healthy eating practices (IPH 2017). FOOD AND NUTRITION LABELLING : CONSUMER PERCEPTION

NHMS 2017

NHMS 2017

• Conducted in Johore Bahru, involving;

 148 female respondents (housewives and working females),  Age 18 years old and above  Consumer awareness, understanding and problems reading nutrition labels Co Consumer umer survey 20 2004 04 (data from Dr. Nik Ismail Nik daud, UKM)

Nutrients of Concerned (2004)

84% 83% 83% 79% 66% 56% 52% 85%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

Fat Cholesterol Salt Sugar Calorie Vitamin & Mineral Dietary fiber Protein

Nutrients Percents

Thank you for you attention

50

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