DRAFT AMENDMENT of REGULATION 26 and NEW TABLE V of FIFTH a SCHEDULE, FOOD REGULATIONS 1985 (Added Nutrient)

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 proposing to amend subregulation (7) of Regulation 26 to prescribe the requirements for nutrient addition 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 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 quality 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.

(b) such food is contain, added, with, or shall contain any statement that may or is likely to convey the same meaning, 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 quality 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 the Fifth A Schedule to outline the nutrient and conditions for each permitted nutrient addition claims:

Permitted Claims Nutrient Condition ‘Enriched’, Vitamins and Minerals Meet minimum level for claim 'high in' in ‘Fortified’, Table II, Fifth A Schedule ‘Strengthened’ or Amino acids and Fatty Meet minimum level for claim 'high in' in ‘Enhanced’ any Acids Table II, Fifth A Schedule other words of similar meaning Other Food Components Meet minimum level for function claims in Table III, Fifth A Schedule ‘Contain’, ‘Added’, Vitamins and Minerals Meet minimum level for claim 'source of' ‘With’, or any other in Table II, Fifth A Schedule words of similar Amino acids and Fatty Meet minimum level for claim 'source of' meaning Acids in Table II, Fifth A Schedule Other Food Components Meet minimum level for function claims in Table III, Fifth A Schedule

* 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 Source@ 0.3 g/100 g acid) 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

** 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 per 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 content

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- 1.5 g per serving i.Claim only permitted in formula dietary foods Methyl Butyrate ii. There shall be written on the label of food Monohydrate adding such nutrient the following statements – (CaHMB) 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 Claim only permitted in infant formula product. DHA and 34 mg/100 kcal of ARA

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 2.5 g per serving - resistant starch

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 (i) This minimum level is specified for infant basis 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 This minimum level is specified for infant formula kcal) 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 0.4g/100ml Claim only permitted for infant formula and 50% (weight over (0.2g/100ml GOS, 0.2 g/100ml PDX) follow-up formula. weight) Galactooligosaccaride (GOS) and 50% (weight over weight) Polydextrose (PDX)

Oat soluble fibre 6.5 g per 100 g (i) Claim for oat soluble fibre (beta-glucan) (Beta-glucan)* only permitted in cereal and cereal based product. *in relation to blood glucose claim (ii) Claim only permitted for cereal and 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- 1.25 g per serving This minimum level is for food other than infant oligosaccharide formula. (FOS) 0.4 g per 100 ml on a ready to drink (i) This minimum level is specified for infant basis formula only.

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 2 g per serving Total fructant content in the mixture shall be mixture containing more than 90 per cent on dry weight basis. containing shorter chain inulin (oligofructose DP 3- 9) and longer chain inulin (inulin DP ≥10) in a 50:50 ratio ± 10% each

Oligosaccharide 0.8 g per 100 ml (i) Claim only permitted in infant formula and mixture containing 90 follow up formula. per cent (weight per weight) galacto- (ii) The component (oligosaccharide mixture) oligosaccharide shall not exceed 0.8 g per 100 ml. (GOS) and 10 per cent (weight per weight) long chain fructo-oligosaccharide (lcFOS)*

*in relation to intestinal immune claim

Oligosaccharide 0.4 g per 100 ml (i) Claim only permitted in infant formula, follow mixture containing 90 up formula and formulated milk powder for per cent (weight per children. weight) galacto- oligosaccharide (ii) The component (oligosaccharide mixture) (GOS) and 10 per shall not exceed 0.8 g per 100 ml. cent (weight per weight) long chain fructo-oligosaccharide (lcFOS)*

*in relation to prebiotic, bifidogenic and intestinal bifidobacteria claim

Patented cooking oil Ratio of fatty acid profiles for The patented cooking oil blend refers to US blend saturated fatty acid:monounsaturated Patent number 5578334 and 5843497. fatty acid:polyunsaturated fatty acid must be 1:1:1

Component Minimum amount required Other conditions Plant sterol or plant 0.4 g per serving in a “free basis” (i) Types of plant sterol or plant stanol stanol or plant sterol form. permitted: ester “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 amount 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 consumption 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

Component Minimum amount required Other conditions Resistant dextrin or 2.5 g per serving Addition and claim for resistant dextrin or resistant maltodextrin resistant maltodextrin are not permitted in infant formula.

Sialic acid 36 mg per 100 kcal or 24 mg per 100 (i) The component (sialic acid) shall not ml 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 making such claim a statement:

“Amount recommended to give the lowering effect on the blood cholesterol is 25 g per day”.