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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 or 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
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)
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
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*
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
25
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 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
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 other words of similar meaning
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
‘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 other 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 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”
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 occurring ganglioside
35
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
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
Galactooligosaccaride(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% 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
• 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 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
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
Consumer survey 2004
(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
Perce
nts
Thank you for you attention
50
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