5.0 Labelling Requirements

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5.0 Labelling Requirements

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Infant, Follow-up, Young Child Formula
Malaysia

This section provides information on labeling requirements and the label approval process.

5.1 Mandatory Labeling Parameters

“Infant, Follow-up and Young Child Formula” should comply with the requirements in Section 5.1 in “5.0 Labelling Requirements” of the “General Foods” and “Special Purpose Foods” guidebooks for Malaysia.

Additionally, there are other labeling items required for “Infant, Follow-up, and Young Child Formula”.

Infant Formula [1][2]

There shall be written in the principal display panel on the label of a package containing infant formula, the words "BREAST MILK IS THE BEST FOOD FOR INFANTS". These words shall be in not less than 10-point size lettering for 500gm cans and the size of the lettering shall increase proportionately with the size of the can
There shall also be written in the principal display panel on the label of a package containing infant formula, in not less than 4 point lettering and in bold, the words: "INFANT FORMULA IS NOT THE ONLY FOOD FOR INFANTS OVER 6 MONTHS OF AGE"
There shall be written on the label of a package containing infant formula, in not less than 4-point lettering:
1. The amount of energy, expressed in kilocalories (kcal) or kilojoules (kJ) or both, and the amount of protein, carbohydrate, fat, vitamin, and mineral contents per 100 gram of the food as sold and as per the specified quantity of the food as suggested for consumption;
2. The words "INFANT FORMULA". The size of the lettering of these words shall be not less than half the height of the lettering for the brand name of the infant formula; and
3. The name of the animal or plant from which the ingredients are derived. The name of the animal or plant shall be written in bold
Where an infant formula is intended for infants with special nutritional requirements, there shall be written on the label of such food the specific requirement for which the formula is to be used and the dietary property or properties on which this is based.
The words "infant formula with iron" shall not appear on the label of any infant formula unless the product contains not less than 1 mg iron (Fe) per 100 available calories.
There shall be written on the label of every package containing infant formula:
1. The method of preparing the food shall include a statement of the quantity or the amount of food directed to be used in the preparation to be given to the infant;
2. A statement suggesting the amount of the prepared food to be given at one time, and the number of times such amount is to be given per day; such statement to be provided for each month of age up to six months;
3. Direction for storage and information regarding its keeping before and after the package has been opened;
4. Instruction for correct preparation and a warning against the health hazards of incorrect preparation
Any descriptive matter appearing on or attached to or supplied with any package of infant formula shall not include any information on the promotion or advertisement of another product.

Follow-up Formula [2][3]

The following details shall be written in the principal display panel on the label of a package containing a follow-up formula:
- The words "BREAST MILK IS THE BEST FOOD FOR INFANT" and these words shall be in not less than 10 point size lettering for 500 g cans and the size of the lettering shall increase proportionately with the size of the can;
- In not less than 4 point lettering, the words "NOT TO BE GIVEN TO INFANTS BELOW 6 MONTHS OF AGE"; and
- In not less than 4 point lettering and in bold, the words "FOLLOW-UP FORMULA IS NOT THE ONLY FOOD FOR INFANTS OVER SIX MONTHS OF AGE".
The following content shall be written on the label on a package of follow-up formula in not less than 4 point lettering:
- The words "FOLLOW-UP FORMULA" and the size of the lettering for these words shall not be less than half the height of the lettering for the brand name of the follow-up formula
- The name of the animal or plant from which the ingredients are derived shall be written in bold;
- The amount of energy, expressed in kilocalories or kilojoules or both, per 100 g of the food as sold as well as per specified quantity of the food as suggested for consumption
- The amount of protein, carbohydrate, and fat per 100 g of the food as sold as well as per specified quantity of the food as suggested for consumption. In addition, the statement per 100 kcal (or per 100 kJ) is permitted
- The total quantity of each vitamin, mineral, and any optional ingredient, per 100 g of the food as sold as well as per specified quantity of the food as suggested for consumption and the declaration per 100 kcal or per 100 kJ is permitted.
Where a follow-up formula is intended for infants with special nutritional requirements, there shall be written on the label of such food the specific requirement for which the formula is to be used and the dietary property on which this is based.
The following shall also be written on the label on a package of follow-up formula:
- The instructions for correct preparation and a warning against the health hazards of incorrect preparation
- A statement suggesting the amount of the prepared food to be given at one time, and the number of times such amount is to be given per day
- Direction for storage and information regarding its keeping before and after the package has been opened
- A statement ""Before deciding to use this product seek the advice of a health professional”.
- Any descriptive matter appearing on or attached to or supplied with any package of follow-up formula shall not include any information on the promotion or advertisement of another product.
"The "Code of Ethics for the Marketing of Infant Foods and Related Products" states that the labels of follow-up formula shall:
- have the statement “Sebelum Membuat Keputusan Untuk Menggunakan Keluaran Ini, Sila Minta Nasihat Profesional Kesihatan.”
- contain information on the recommended retail price
- have the name of the animal or plant from which the major ingredients are derived written on the Ingredient List in bold characters;
- have the following statements in the principal display panel of the label:
  - the Approval Code from the Vetting Committee.
  - “SUSU IBU ADALAH MAKANAN YANG TERBAIK UNTUK BAYI” for follow-up formula. These words should be in bold lettering and not less than 10 points in size for a 500 g tin and below. The size of the lettering should increase proportionately with the size of the tin.
  - the appropriate designation eg. RUMUSAN SUSULAN for the follow-up formula. These words should be more prominent in visual emphasis and position and not less than half the height when compared with the brand name of the formula.
  - “RUMUSAN SUSULAN BUKANLAH MAKANAN TUNGGAL BAGI BAYI YANG BERUMUR LEBIH DARIPADA 6 BULAN” for follow-up formula. These words should be in bold lettering and not less than 4 points in size for a 500 g tin and below. The size of the lettering should increase proportionately with the size of the tin.
  - “TIDAK BOLEH DIBERIKAN KEPADA BAYI YANG BERUMUR DI BAWAH 6 BULAN” for follow-up formula."

Young Child Formula [4]

There shall be written on the label of a package containing formulated milk powder for children:

(a) in not less than 12-point lettering, except for packages below 250 g

the words “Formulated milk powder for children”; and
the recommended age group;

(b) in not less than 10-point lettering and in bold the following statements:

“NOT SUITABLE FOR INFANTS BELOW TWELVE (12) MONTHS OF AGE”;
“BREASTS MILK IS THE BEST FOOD FOR INFANTS”; and
“THIS PRODUCT IS NOT THE ONLY FOOD FOR CHILDREN”.

(c) The amount of energy expressed in kilocalories (kcal) per 100 g or per package, or expressed in kilojoule (kJ) per 100 g or per package if the package contains only a single portion and per serving as quantified on the label;

(d) The amount of protein, fat, and carbohydrate expressed in grams per 100 g or per package if the package contains only a single portion and per serving as quantified on the label;

(e) The amount of nutrients specified in column (1) of Table I to the Sixteenth AA Schedule expressed per 100 g or per package if the package contains only a single portion and per serving as quantified on the label;

(f) The method of preparing the food which shall include a statement of the quantity or the amount of food directed to be used in the preparation to be given to the children;

(g) A statement suggesting the amount of the prepared food to be given at one time, and the number of times such amount is to be given per day; and

(h) Direction for storage and information regarding its keeping before and after the package has been opened.

5.2 Languages

All particulars required to appear on the label on the package of Special Purpose Foods including Infant, Follow-up, and Young Child Formula shall be in Bahasa Malaysia and may include translation thereof in any other language.

5.3 Mandatory Information on Stickers

“Infant, Follow-up and Young Child Formula” should comply with the requirements in Section 5.3 of “5.0 Labelling Requirements” of the “General Foods” guidebook for Malaysia.

5.4 Product Legal Name

Infant Formula

Infant Formula [1]

Follow-up Formula

Follow-up formula [3]

Young Child Formula

Formulated milk powder for children [4]

5.5 Product-specific Labeling Statements

Infant Formula [1][7]

The "Code of Ethics for the Marketing of Infant Foods and Related Products" states that the label of infant formula shall:

Have the statement “Sebelum Membuat Keputusan Untuk Menggunakan Keluaran Ini, Sila Minta Nasihat Profesional Kesihatan.”
Contain information on the recommended retail price
Have the name of the animal or plant from which the major ingredients are derived written on the Ingredient List in bold characters
Have the following statements in the principal display panel of the label:
1. the Approval Code from the Vetting Committee.
2. “SUSU IBU ADALAH MAKANAN YANG TERBAIK BAGI BAYI” for infant formula. These words should be in bold lettering and not less than 10 points in size for a 500 g tin and below. The size of the lettering should increase proportionately with the size of the tin.
3. the appropriate designation eg. RUMUSAN BAYI for infant formula. These words should be more prominent in visual emphasis and position and not less than half the height when compared with the brand name of the formula.
4. “RUMUSAN BAYI BUKANLAH MAKANAN TUNGGAL BAGI BAYI YANG BERUMUR LEBIH DARIPADA 6 BULAN” for infant formula. These words should be in bold lettering and not less than 4 points in size for a 500 g tin and below. The size of the lettering should increase proportionately with the size of the tin.

Follow-up Formula [3][7]

The "Code of Ethics for the Marketing of Infant Foods and Related Products" states that the labels of follow-up formula shall:

Have the statement “Sebelum Membuat Keputusan Untuk Menggunakan Keluaran Ini, Sila Minta Nasihat Profesional Kesihatan.”
Contain information on the recommended retail price
Have the name of the animal or plant from which the major ingredients are derived written on the Ingredient List in bold characters;
Have the following statements in the principal display panel of the label:
1. the Approval Code from the Vetting Committee.
2. “SUSU IBU ADALAH MAKANAN YANG TERBAIK UNTUK BAYI” for follow-up formula. These words should be in bold lettering and not less than 10 points in size for a 500 g tin and below. The size of the lettering should increase proportionately with the size of the tin.
3. the appropriate designation eg. RUMUSAN SUSULAN for follow-up formula. These words should be more prominent in visual emphasis and position and not less than half the height when compared with the brand name of the formula.
4. “RUMUSAN SUSULAN BUKANLAH MAKANAN TUNGGAL BAGI BAYI YANG BERUMUR LEBIH DARIPADA 6 BULAN” for follow-up formula. These words should be in bold lettering and not less than 4 points in size for a 500 g tin and below. The size of the lettering should increase proportionately with the size of the tin.
5. “TIDAK BOLEH DIBERIKAN KEPADA BAYI YANG BERUMUR DI BAWAH 6 BULAN” for follow-up formula.

5.6 Authority Approval

Infant Formula and Follow-up Formula

Labels of designated products (infant formula (for infants 0-12 months) and follow-up formula (for infants 6 months to 3 years)) are required to be submitted to the Vetting Committee for approval. The vetting Committee on the Code of Ethics for the Marketing of Infant Foods and Related Products is the authority in charge. No cost for label vetting and the timeline is about 6 months.

Refer to Section 8.0 - Registration Processes - for details.

Young Child Formula

No mandatory product label approval process. No cost for label approval.

5.7 Additional Notes on Labeling

There are additional labeling requirements on the form and manner of labeling, and the size and color of letters required for general foods that should be followed.

Refer to Section 5.7 in “5.0 Labeling Requirements" of the "General Foods" guidebook for Malaysia.