NUTRITION LABELLING AND CLAIMS: REGULATORY UPDATES IN MALAYSIA

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Harvey Hodge
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Quality Division Ministry of Health Malaysia NSM

1 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 July 2018

2 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

3 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

4 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 Nutrient content claim [Regulation

level of a nutrient contained in a food Claim that compares

Nutrient function claim [Regulation 18E] Describe the

& normal functions of the body Claim for enrichment,

5 PERMITTED NUTRITION CLAIMS Nutrient content claim [Regulation 18C] Nutrient comparative claim [Regulation 18D] Describe the level of a nutrient contained in a food Claim that compares the nutrient levels or energy value of 2 or more product Nutrient function claim [Regulation 18E] Describe the physiological role of the nutrient in the growth, development & normal functions of the body Claim for enrichment, fortification [Regulation 26] Describe the level of a nutrient contained in a food

6 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

7 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)

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

9 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 Free 0.04 g per 100 g(solid) or 0.02 g per 100 ml (liquid) g per 100 g(solid) or g per 100 ml (liquid)

1 g per 100 ml (liquids) COMPONENT CLAIM NOT MORE THAN

10 NUTRIENT CONTENT CLAIM COMPONENT CLAIM Trans Fatty Acids Free NOT MORE THAN 0.1 g per 100 g (solids) or 0.1 g per 100 ml (liquids) COMPONENT CLAIM NOT MORE THAN Cholesterol Free g per 100 g (solids) or g per 100 ml (liquids)

11 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 of ) 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)

12 NUTRIENT COMPARATIVE CLAIMS Reduced, less than, fewer, light Increased, more than extra A product that has a new formulation with lower or reduced nutrient level A product that has a new formulation with increased or extra nutrient level

13 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

14 NUTRIENT COMPARATIVE CLAIM Less in cholesterol This eggs have lower cholesterol level (112mg / 2 pcs) as compared to regular eggs 432mg / 2 pcs To claim this product is less in cholesterol, below is the criteria; Nutrient content between compared foods must differ by at least 25%

15 NUTRIENT COMPARATIVE CLAIM

16 NUTRIENT COMPARATIVE CLAIM Less in sugar To claim this product is less in sugar, below is the criteria; Nutrient content between compared foods must differ by at least 25%

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.

17 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.

18 NUTRIENT FUNCTION CLAIM CLASSICAL NUTRIENTS Nutrient Vitamin A Vitamin B 1 /Thiamine Vitamin B 2 / Riboflavin Vitamin B 12 / Cyanocobalamine Vitamin C Vitamin D Vitamin E Zinc Claim Vitamin A aids is maintaining the health of skin and mucous membrane Vitamin A is essential for the functioning of the eyes Vitamin B 1 /Thiamine is needed for the release of energy from carbohydrate Vitamin B 2 / Riboflavin is needed for the release of energy from protein, fats and carbohydrate Vitamin B 12 / Cyanocobalamine is needed for red blood cell production Vitamin C enhances absorption of iron from non-meat source Vitamin C contributes to the absorption of iron from food Vitamin D helps the body utilize calcium and phosphorus Vitamin D is necessary for the absorption and utilization of calcium, and phosphorus Vitamin E protects the fat in body tissues from oxidation Zinc is essential for growth protects the fat in body tissues from oxidation

19 OTHER FUNCTION CLAIM OTHER FOOD COMPONENTS Nutrient Beta glucan Inulin and oligofructose (fructooligosaccharide) Claim Beta glucan from (state the source-oat/barley) helps lower or reduce cholesterol* 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 Sialic acid Plant sterol / plant stanol helps lower or reduce cholesterol* Sialic acid is an important component of brain tissues*

20 OTHER FUNCTION CLAIM OTHER FOOD COMPONENTS Nutrient Beta glucan Bifidobacterium lactis DHA and ARA HAMRS Isomaltulose Claim Beta glucan from (barley) helps lower or reduce cholesterol* Bifidobacterium lactis helps improve a beneficial intestinal microflora* Bifidobacterium lactis may help to reduce the incidence of diarrhea* DHA and ARA may contribute to the visual development of infant* High Amylose Maize Resistant Starch (HAMRS) helps improve / promote colonic/bowel/intestinal function/ environment* 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*

21 OTHER FUNCTION CLAIM OTHER FOOD COMPONENTS Nutrient Oat soluble fibre (betaglucan) Oligosaccharide mixture containing 90%(wt/wt) GOS and 10% (wt/wt) lcfos Claim 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 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*

22 OTHER FUNCTION CLAIM OTHER FOOD COMPONENTS Nutrient Patented cooking oil blend Plant sterol ester Polydextrose Claim Patented cooking oil blend helps to increase HDL Cholesterol and improve HDL/LDL cholesterol ratio* Plant sterol ester helps lower or reduce cholesterol* Polydextrose is bifidogenic* Polydextrose helps increase intestinal bifidobacteria and helps maintain a good intestinal microflora* Resistant dextrin / Resistant maltodextrin Soy protein 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 helps to reduce cholesterol*

23 NUTRIENT FUNCTION CLAIM

25 UPDATES ON NUTRITION LABELLING TABLE I, TWELFTH SCHEDULE Permitted added nutrient (343 ) Vitamin and Mineral Vit K1, Vit K2 Amino Acids Fatty Acids Nucleotides Other food component Epigallocatechin gallate (EGCG) -Dietary Fibre 25

26 UPDATES ON NUTRITION LABELLING * Gazetted in 31 st March 2017 Reg. 26 (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 26

27 UPDATES ON NUTRITION LABELLING Reg. 26 (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. 27

28 PROHIBITED CLAIMS Claims stating that any particular food will provide an adequate source of all essential nutrients Claims implying that a balanced diet or a combination of a variety of foods cannot supply adequate amounts of 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

29 PROPOSED AMENDMENT

30 PROPOSED AMENDMENT Table V - Condition for claim related for added nutrient Permitted Nutrient Conditions Claims enriched, fortified, strengthened, enhanced or any other words of similar meaning contain, added, with, or other words of similar meaning vitamin and mineral Other food components Vitamin and mineral Other food components Meet minimum level for claim high in in fifth Sch Meet minimum level for other function claims in Fifth A Sch Meet minimum level for claim source of in Fifth Sch Meet minimum level for other function claims in Fifth Sch

31 Claims No added sugars Criteria: PROPOSED AMENDMENT 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.

32 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.

33 PROPOSED AMENDMENT New content claim & conditions Table 1 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 only permitted in food consisting of one or more ingredients from wheat, rye, barley, oats or their crossbred varieties, which have been specially processed to reduce the gluten content

34 PROPOSED AMENDMENT New content claim & conditions 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 occurring ganglioside

35 PROPOSED AMENDMENT 3. Related to Permitted Claims Reg 18F. Definition of Other Function Claim a claim that describes specific beneficial effect of other food component in food that gives : a) positive contribution to health or b) improvement of a function of the body 35

36 PROPOSED AMENDMENT Table III Condition for Other Function Claims Component Claims Minimum amount required Calcium 3- hydroxy-3- methyl butyrate monohydrate (CaHMB) (i) CaHMB helps to regain strength (ii) CaHMB supports tissue building 1.5 g per serv Condition 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.

37 PROPOSED AMENDMENT Table III Condition for Other Function Claims 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

38 PROPOSED AMENDMENT Table III Condition for Other Function Claims 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% of 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

39 Procedure for approval of Nutrition Claims 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)

40 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

41 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 other organizations 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

42 AMENDMENT PROCESS

43 FOOD AND NUTRITION LABELLING : CONSUMER PERCEPTION Food and nutrition labelling has been recognized as one of the strategies to encourage people to adopt healthy eating practices (IPH 2017).

44 NHMS 2017

45 NHMS 2017

47 Consumer survey 2004 (data from Dr. Nik Ismail Nik daud, UKM) 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

48 Nutrients of Concerned (2004) Percents 90% 80% 70% 60% 50% 40% 30% 85% 84% 83% 83% 79% 66% 56% 52% 20% 10% 0% Fat Cholesterol Salt Sugar Calorie Vitamin & Mineral Dietary fiber Protein Nutrients

49 Thank you for you attention

CONTACT +603 8885 0797 +603 8885 0790 norrani@moh.gov.my http://fsq.moh.gov.my hppt://www.

50 CONTACT hppt:// 50

10 th Seminar on. Nutrition Labeling, Claims and Communication Strategies OUTLINE OF THE PRESENTATION STATUS OF NUTRITION LABELLING.

10 th Seminar on. Nutrition Labeling, Claims and Communication Strategies OUTLINE OF THE PRESENTATION STATUS OF NUTRITION LABELLING. 10 th Seminar on Nutrition Labeling, Claims and Communication Strategies August 28 29, 2018 Renaissance Hotel, Kuala Lumpur, Malaysia NUTRITION LABELLING AND CLAIMS: REGULATORY UPDATES IN MALAYSIA Norrani