Outline of presentation STATUS OF NUTRITION LABELLING. Claims Regulations in Malaysia

Transcription

1 Updates on Nutrition Labeling and Claims Regulations in Malaysia Norrani Eksan Food Safety and Quality Division Ministry of Health Malaysia Outline of presentation Status of nutrition labelling and claims Nutrition labelling Conditions for nutrition claims Procedure for approval of nutrition claim Proposed amendment ILSI Seminar, Manila, Philippines August 4, STATUS OF NUTRITION LABELLING. 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 4

2 Nutrition Labelling and Claims in Malaysia 2 parts: Nutrition labelling only mandatory for certain food group. Declaration of energy value, carbohydrate, protein and fat Specific provisions for claims such as nutrient content claim, nutrient function claim and nutrient comparative claim 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. 5 6 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 Categories of Foods That Require Mandatory Nutrition Labelling 7 8

3 LABELLING OF MANDATAORY NUTRIENTS LABELLING OF MANDATAORY NUTRIENTS Solid Food Energy Carbohydrate, Protein, Fat Must declare Energy Protein Carbohydrate Liquid Food Energy Carbohydrate, Protein, Fat Total Sugars (Ready to drink beverage) Fat Single Portion Column for nutrient listing Column for per package/per serving (Total sugars only for ready to drink beverages) 9 10 LABELLING OF OPTIONAL NUTRIENTS CLAIMS ON FOOD LABELS Permitted Claims* Prohibited Claims 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 Nutrient content claim Nutrient comparative claim Nutrient function claim Other function claim Nutrient enrichment or fortification claim Nutritious Claim 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 * Must meet condition required for making claims 11 12

4 HEALTH CLAIMS (disease risk reduction claim) Example that is Prohibited in Malaysia EXAMPLS OF OTHER PROHIBITED CLAIMS 13 FUNCTION CLAIM VS HEALTH CLAIM NUTRITION CLAIMS FUNCTION CLAIM Describe the specific role of the nutrient in relation to physiological functions Ex: Iron is a factor in red blood cell formation. Calcium aids in the dev of strong bones and teeth HEALTH CLAIM Suggest or implies a relationship between a food and health condition Health claim such as disease risk reduction claims are not permitted Ex: Iron can help reduce the risk of anemia 1. Nutrient content claim 2. Nutrient comparative claim 3. Nutrient function claim 4. Claim for enrichment, fortification or other words of similar meaning 15 16

5 CONDITIONS : NUTRIENT CONTENT CLAIMS NUTRIENT CONTENT CLAIM 17 CONDITIONS : NUTRIENT CONTENT CLAIMS NUTRIENT CONTENT CLAIM 19

6 CONDITIONS : NUTRIENT COMPARATIVE CLAIMS A product that has new formulation with REDUCED or EXTRA nutrient level NUTRIENT COMPARATIVE CLAIM 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 ) 21 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. Nutrient Calcium Folic acid Iron Iodine Magnesium Niacin Protein NUTRIENT FUNCTION CLAIM CLASSICAL NUTRIENTS Claim Calcium aids in the development of strong bones and teeth 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 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 is essential for the formation of thyroid hormone Magnesium promotes calcium absorption and retention Niacin is needed for the release of energy from protein, fats and carbohydrate 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/

7 NUTRIENT FUNCTION CLAIM NUTRIENT FUNCTION CLAIM Nutrient Vitamin A Vitamin B 1 /Thiamine Vitamin B 2 / Riboflavin Vitamin B 12 / Cyanocobalamine Vitamin C Vitamin D Vitamin E Zinc NUTRIENT FUNCTION CLAIM CLASSICAL NUTRIENTS 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 28

8 Nutrient Beta glucan Plant sterol / plant stanol Sialic acid OTHER FUNCTION CLAIM OTHER FOOD COMPONENTS Claim Beta glucan from (oat soluble fibre) 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 helps lower or reduce cholesterol* Sialic acid is an important component of brain tissues* Gazetted : P.U.(A) 88/2003 & P.U.(A) 306/2009 * Specific condition required 29 Nutrient Beta glucan Bifidobacterium lactis DHA and ARA HAMRS Isomaltulose Lutein OTHER FUNCTION CLAIM OTHER FOOD COMPONENTS Claim Beta glucan from (barley) helps lower or reduce cholesterol* Bifidobacterium lactis helps improve a beneficial intestinal microflora* Bifidobacteriumlactis 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* As a predominant macular pigment in the retina, Lutein is able to filter blue light and may protect the eye* * Specific condition required 30 Nutrient Oat soluble fibre (beta- glucan) Oligosaccharide mixture containing 90%(wt/wt) GOS and 10% (wt/wt) lcfos Inulin and oligofructose (fructooligosaccharide) Oligofructoseinulin mixture OTHER FUNCTION CLAIM OTHER FOOD COMPONENTS 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 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 required 31 Nutrient Patented cooking oil blend Plant sterol ester Polydextrose Resistant dextrin / Resistant maltodextrin Soy protein OTHER FUNCTION CLAIM OTHER FOOD COMPONENTS 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 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* * Specific condition required 32

9 CONDITIONS : OTHER FUNCTION CLAIM Specific conditions required for other function claim Minimum amount of the relevant food component that must be present Additional labelling requirements, if relevant Restriction to selected foods, if relevant GUIDE TO NUTRITION LABELLING AND CLAIMS ü Updates on Nutrition Labelling & Claims Regulations üto assist industry and enforcement officers understand the regulation üwebsite 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. 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 I Secretariat will present proposal to regulate or amend to related Expert Working Group STEP II Consultation with industry and stakeholders involved STEP III Food Regulations 1985 Advisory Committee will deliberate the proposal from the expert working group STEP IV Proposed amendment draft will be published for public consultation STEP V The draft amendment for gazattement will be prepared after comments STEP VI Draft 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 VII Regulations gazetted and printed

10 2. Nutrition Labelling Expand the NRV List 1. Nutrition Labelling Additional information on % NRV q In additional, nutrition information SHALL be expressed as a % of NRV q Based on energy needs = 2000 kcal 37 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 Riboflavin mg Niacin mg Vitamin B6 mg Vitamin B12 µg Calcium mg 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 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) 39 KEY MESSAGES 1. 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 40

11 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 * 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 Component Claim Not MoreThan Gluten Free 0.002g per 100g (solids or liquids) 5. Nutrient Comparative Claim Reduced Gluten Food consisting of one or more ingredients from wheat (all Triticum species) which have been specially processed to reduce the gluten content Level of gluten content in total : 0.002g 0.01g per 100g * 6. Other Function Claims (New Components) Component Claim Specific Condition D-Ribose helps to promote energy recovery during or after physical activities Calcium 3-hydroxy- 3-methyl butyrate monohydrate (CaHMB) a) help to regain strength b) supports tissue building - Min amount: 3g per serving - Formula dietary foods - Additional labelling requirements Do not exceed 2 servings per day - 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 7. Other Function Claims (Minimum Amount Required Revised) Component : Inulin Existing Regulation PU(A) 306/2009 Director s written approval (2009) 2g per serving 1.25g per serving * 43 44

12 8. Other Function Claims (Minimum Amount Required Revised) Existing Regulation PU(A) 306/2009 (Plant sterol / plant stanol ) Component : Plant sterol / plant stanol / plant sterol Director s written approval (2010) 1.3g per 100g (solids) 160mg per 100ml (liquids) 0.65g per serving 0.4g per serving (in a free basis form) 9. Other Function Claims (Minimum Amount Required Revised) Component : Oligofructose-inulin mixture Director s written approval (2008) Revised Oligofructose-inulin mixture containing 36-42% oligofructose (DP 2-10) and % inulin (DP >10) helps to increase calcium absorption and increase bone mineral density when taken with calcium rich food 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 food PROPOSED AMENDMENT * xx. Other Function Claims (New Components) xx. Maximum amount for Vitamins & Minerals Component Claim Specific Condition Beta palmitin Mixture containing 50% (weight over weight) Galactooligosaccharide (GOS) and 50% (weight over weight) Polydextrose (PDX) i. Beta palmitin contributes to increased calcium absorption ii. Beta palmitin contributes to increased fat absorption 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 ; (i) >18% C16:0 content based on total fatty acids (ii) > 40% C16:0 in sn-2 position based on total C16:0 content - Claim only permitted for infant formula and follow-up formula g/100ml (0.2g/100ml GOS, 0.2 g/100ml PDX) 47 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 - 48

13 xx. Claims Related to Nutrient Addition Permitted Claims Nutrient Condition xx. Claims Related to Nutrient Addition (con t) Enriched, Fortified, Strengthened or Enhanced any other words of similar meaning Contain, Added, With, or any other words of similar meaning Vitamins and Minerals Amino acids & Fatty Acids Other Food Components Vitamins and Minerals Amino Acids & Fatty Acids Other Food Components Meet minimum level for claim 'high in' in Table II, Fifth A Schedule Meet minimum level for claim 'high in' in Table II, Fifth A Schedule Meet minimum level for function claims in Table III, Fifth A Schedule Meet minimum level for claim 'source of' in Table II, Fifth A Schedule Meet minimum level for claim 'source of' in Table II, Fifth A Schedule Meet minimum level for function claims in Table III, Fifth A Schedule Component Ganglioside Conditions for Declaration of Naturally Occurring Nutrient Minimum Amount Required 11mg / 100g Naturally Occurring Nutrient Meet minimum level for label declaration FRONT OF PACK LABELLING Objective Why based on 2000kcal? give a quick picture about calorie content in a product to allow consumer to plan and control the daily energy intake as needed, especially high-calorie foods 2000 calories is based on daily average of energy requirement of a normal adult Based on 2000kcal 51 52

14 PROMOTING ROMOTING THE UNDERSTAND AND USE O OF NUTRITION L LABELLING AND D CLAIMS PROMOTING ING THE UNDERSTAND OF NUTRITION NU LABELLING AND CLAIMS LABE Nutrition Information Centre CONTACT Thank you for you attention norrani@moh.gov.my hppt:// 55