1 
 DRAFT AMENDMENT OF REGULATION 26  AND NEW TABLE V OF FIFTH A 
SCHEDULE, FOOD REGULATIONS 1985  
(Added Nutrient)  
 
 
1) Draft Amendment of Regulation 26  
Malaysia is prop osing to amend subregulation (7) of Regulation 26 to prescribe the 
requirements for nutrient add ition claims as follows : 
 
No label on a package containing any food shall bear a claim that:  
  
“(a)  such food is enriched, fortified, strengthened or enhanced, or shall contain any 
statement that may or is likely to convey the same meaning, unless it meet s the criteria 
as specified in Table V to the Fifth A Schedule . Where any food is claimed to posses 
the quality as aforesaid there shall be written in the label on a package containing such 
food, the words “This food is (state the quality claimed) with (st ate the vitamins, 
minerals, other food component, amino acids or fatty acids and their amounts in units)” 
or other words of similar meaning.  
 
(b)  such food is contain, added, with, or shall contain any statement that may or is likely to 
convey the same me aning, unless it meets the criteria as specified in Table V to the 
Fifth A Schedule . Where any food is claimed to posses the quality as aforesaid there 
shall be written in the label on a package containing such food, the words “This food is 
(state the qual ity claimed) with (state the vitamins, minerals, other food component, 
amino acids or fatty acids and their amounts in units)” or other words of similar 
meaning.”; and  
 
 
2) New Table V  of Fifth A Schedule  
Malaysia is also proposing to add a new Table V to th e Fifth A Schedule to outline the 
nutrient and conditions for each permitted nutrient addition claims:  
 
Permitted Claims  Nutrient  Condition  
‘Enriched’, 
‘Fortified’, 
‘Strengthened’ or 
‘Enhanced’ any 
other words of 
similar meaning  Vitamins and Minerals  Meet  minimum level for claim 'high in' in 
Table II, Fifth A Schedule  
Amino acids and 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 Schedul e 
‘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 and Fatty 
Acids  Meet minimum level for claim 'source of' 
in Table II, Fifth A Sc hedule  
Other Food Components  Meet minimum level for function claims in 
Table III, Fifth A Schedule  2 
 * Table II of the Fifth A Schedule :  
 
TABLE II  
CONDITIONS FOR NUTRIENT CONTENTS FOR USE OF NUTRITION CLAIMS  
Component  Claim  Conditions  
B.  Not Less Than  
Protein*  Source  
 
 
 10 per cent of NRV per 100 g (solids)  
5 per cent of NRV per 100 ml (liquids)  
or 5 per cent of NRV per 100 kcal  
 
High at least 2 times the values for “source”  
 
Vitamins and Minerals  Source  
 
 
 15 per cent of NRV per 100 g (solids)  
7.5 per cent of NRV per 100 ml 
(liquids)  
or 5 per cent of NRV per 100 kcal  
 
High at least 2 times the values for “source”  
 
Total Dietary Fibre  
 Source  
 
 3 g per 100 g (solids)  
1.5 g per 100 ml (liquids)  
 
High 6 g per 100 g (solids)  
3 g per 100 ml (liquids ) 
 
Omega 3 (alpha -linolenic 
acid)  Source@  0.3 g/100 g  
 
High@  0.6 g/100 g  
 
 
Note:  (*)  Nutrient Reference Value  
  Protein (g) 50;  
@  These claim are 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  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 3 
 ** Table III of the Fifth A Schedule:  
 
“TABLE III  
CONDITIONS FOR OTHER FOOD COMPONENT CONTENTS FOR USE OF NUTRITION CLAIMS  
Component  Minimum amount required  Other conditions  
Beta-glucan  0.75 g pe r serving  (i) Source of beta glucan shall be from oat and 
barley.  
 
(ii) The food to be added with beta -glucan 
shall also contain total dietary fibre for not 
less than amount required to claim as 
“source”:  
 
3 g per 100 g (solids)  
 
1.5 g per 100 ml (liquids)  
 
(iii) There  shall be written on the label these 
following statement:  
 
“Amount recommended for cholesterol 
lowering effect is 3 g per day”  
 
Beta Palmitin  
 (i) >18% C16:0 content based on total 
fatty acids  
 
(ii) > 40% C16:0 in sn -2  
position based on total C16:0 con tent  
 - 
Bifidobacterium lactis  1 x 106  minimum viable cells per g  
  Claim only permitted in infant formula, follow -up 
formula, formulated milk powder for children and 
cereal based food for infant and children.  
 
Calcium 3 -Hydroxy -3-
Methyl Butyrate 
Mono hydrate 
(CaHMB)  1.5 g per serving  i.Claim only permitted in formula dietary foods  
ii. There shall be written on the label of food 
adding such nutrient the following statements – 
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 
advice” on the principal display panel.  
 
DHA and ARA  A combination of 17 mg/100 kcal 
DHA and 34 mg/100 kcal of ARA  
 Claim only permitted in infant formula produc t. 
 
D-ribose  3 g per serving  i. Claim only permitted in formula dietary foods  
ii. There shall be written on the label of food 
adding such nutrient a statement “Do not exceed 
2 servings per day”.  
 
High amylose maize 
resistant starch  
 
 2.5 g per serving  - 4 
 Component  Minimum amount required  Other conditions  
Inulin  
 
 1.25 g per serving  This minimum level is for food other than infant 
formula.  
 
0.4 g per 100 ml on a ready to drink 
basis  
 (i) This minimum level is specified for infant 
formula only.  
 
(ii) The component (inulin and 
oligofructose/fructo -oligosaccharide (FOS )) 
shall not exceed 0.6 g per 100 ml  
 
Isomaltulose  15 g per serving  Addition and claim for isomaltulose are not 
permitted in infant formula.  
 
Lutein  
 
 2.5 μg per 100ml (3.7 μg per 100 
kcal)  
 This minimum level is specified for infant formula 
only.  
20 μg per 100ml (30 μg per 100 kcal)  This minimum level is specified for follow up 
formula only.  
 
20 μg per 100ml (20 μg per 100 kcal)  This minimum level is specified for formulated 
milk powder for children only.  
 
Mixture containing 
50% (weight over 
weight) 
Galactooligosaccaride 
(GOS) and 50% 
(weight over weight) 
Polydextrose (PDX)  
 0.4g/100ml  
(0.2g/100ml GOS, 0.2 g/100ml PDX)  Claim only permitted for i nfant formula and 
follow -up formula.  
 
Oat soluble fibre  
(Beta-glucan)*  
 
*in relation to blood 
glucose claim  
 6.5 g per 100 g  (i) Claim for oat soluble fibre ( beta-glucan) 
only permitted in cereal and cereal based 
product.  
 
(ii) Claim only permitted for cereal a nd cereal 
based product where the macronutrient 
profile (carbohydrate, protein and fat) 
complies with Recommended Nutrient 
Intake (RNI) Malaysia.  
 
(iii) There shall be written on the label of cereal 
and cereal based product making such 
claim a statement:  
 
(iv) “For advice regarding consuming this 
product, consult your health professional”  
 
Oligofructose/ fructo -
oligosaccharide 
(FOS)  
 1.25 g per serving  This minimum level is for food other than infant 
formula.  
 
0.4 g per 100 ml on a ready to drink 
basis  
 (i) This mini mum level is specified for infant 
formula only.  
 5 
 Component  Minimum amount required  Other conditions  
(ii) The component (inulin and 
oligofructose/fructo -oligosaccharide 
(FOS)) shall not exceed 0.6 g per 100 ml.  
 
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  
 2 g per serving  Total fructant content in the mixture shall be 
more than 90 per cent on dry weight basis.  
Oligosaccharide 
mixture containing 90 
per cent (weight per 
weight) galacto -
oligosaccharide 
(GOS ) and 10 per 
cent (weight per 
weight) long chain 
fructo -oligosaccharide 
(lcFOS)*  
 
*in relation to 
intestinal immune 
claim  
 0.8 g per 100 ml  (i) Claim only permitted in infant formula and 
follow up formula.  
 
(ii) The component (oligosaccharide mixture) 
shall not exceed  0.8 g per 100 ml.  
 
Oligosaccharide 
mixture containing 90 
per cent (weight per 
weight) galacto -
oligosaccharide 
(GOS) and 10 per 
cent (weight per 
weight) long chain 
fructo -oligosaccharide 
(lcFOS)*  
 
*in relation to prebiotic, 
bifidogenic and 
intestinal bifi dobacteria 
claim  
 0.4 g per 100 ml  (i) Claim only permitted in infant formula, follow 
up formula and formulated milk powder for 
children.  
 
(ii) The component (oligosaccharide mixture) 
shall not exceed 0.8 g per 100 ml.  
 
 
 
Patented cooking oil 
blend  Ratio of fatty aci d profiles for 
saturated fatty acid:monounsaturated 
fatty acid:polyunsaturated fatty acid 
must be 1:1:1  
 
 
 
 
 The patented cooking oil blend refers to US 
Patent number  5578334 and 5843497.  
 
 6 
 Component  Minimum amount required  Other conditions  
Plant sterol or plant 
stanol or plant sterol 
ester  
 0.4 g per s erving in a “free basis” 
form.  
 (i) Types of plant sterol or plant stanol 
permitted:  
 
“plant sterol or plant stanol, phytosterols or 
phytostanol, sitosterol, campesterol, 
stigmasterol or other related plant stanol”  
 
(ii) Types of plant sterol esters permitted:  
 
“campesterol ester, stigmasterol ester and 
beta-sitosterol ester”  
 
(iii) Amount of plant sterol or plant stanol or plant 
sterol ester in a “free basis” form to be added 
in food shall not exceed 3 g plant sterol or 
plant stanol per day.  
 
(iv) Declaration of the total a mount of plant sterol 
or plant stanol or plant sterol ester contained 
in the products shall be expressed in metric 
units per 100 g or per 100 ml or per package 
if the package contains only a single portion 
and per serving as quantified on the label.  
 
(v) Only the terms “plant sterol” or “plant stanol” 
or “plant sterol ester” shall be used in 
declaring the presence of such components.  
 
(vi) There shall be written on the label of food 
making such claim the following statements:  
 
(a) “Not recommended for pregnant and 
lactating women, and children under the 
age of five years”;  
 
(b) “Persons on cholesterol -lowering 
medication shall seek medical advice 
before consuming this product”;  
 
(c) “That the product is consumed as part 
of a balanced and varied diet and shall 
include regular c onsumption of fruits 
and vegetables to help maintain the 
carotenoid level”; and  
 
(d) “With added plant sterols or plant stanol 
or plant sterol ester” in not less than 10 
point lettering”.  
 
Polydextrose  1.25 g per serving  
 
 
 
  7 
 Component  Minimum amount required  Other conditions  
Resistant dextrin or 
resistant maltodextrin  
 2.5 g per serving  Addition and claim for resistant dextrin or 
resistant maltodextrin are not permitted in infant 
formula.  
 
Sialic acid  36 mg per 100 kcal or  24 mg per 100 
ml 
 
 (i) The component (sialic acid) shall  not 
exceed 67 mg per 100 kcal (45 mg per 100 
ml). 
 
(ii) Addition and claim only permitted in infant 
formula and follow up formula.  
 
(iii) Only natural sialic acid from milk shall be 
added.  
 
Soy protein  
 5 g per serving  
 There shall be written on the label of food m aking 
such claim a statement:  
 
“Amount recommended to give the lowering 
effect on the blood  cholesterol is 25 g per day”.