6.0 Claim Requirements

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6.0 Claim Requirements

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Infant, Follow-up, and Young Child Formula
Singapore

This section provides information on the definition of different types of claims and any restrictions or allowance of claims as well as claim registration processes.

6.1 Overview of Claims

6.1.1 Types & Definitions

“Nutrition claim” means a representation that suggests or implies that a food has a nutritive property, whether general or specific and whether expressed affirmatively or negatively and includes reference to energy; salt, sodium or potassium; amino acids, carbohydrates, cholesterol, fats, fatty acids, fiber, protein, starch or sugars; vitamins or minerals; or any other nutrients.

Health Claims - Nutrient function claims and other function claims

"Health claim" means any representation that states, suggests, or implies that a relationship exists between a food or a constituent of that food and health. It includes nutrient function claims, other function claims, and reduction of disease risk claims.

6.1.2 List of Prohibited Claims

Infant Formula and Follow-up Formula [2,6]

No claims or suggestion whether in the form of a statement, word, brand, picture, or mark purporting to indicate the nature, stability, quantity, strength, purity, composition, weight, origin, age, effects, or proportion of food or its ingredients that is false, misleading or deceptive, or is likely to create an erroneous impression regarding the value, merit or safety of the food. Signs and symbols may sometimes be used in a manner that is false, misleading, or deceptive to create an erroneous impression regarding the value, merit, and safety of the food.
No claims to suggest or imply that (i) the food has therapeutic or prophylactic action; (ii) the food will prevent, alleviate, or cure any disease or condition affecting the human body; or (iii) that health or an improved physical condition may be achieved by consuming the food.
No claim or suggestion may be interpreted as advice of a medical nature from any person whatsoever.
The label on a package of any infant formula for infants, or an advertisement about any infant formula for infants, must NOT contain:
- A claim that states, suggests, or implies that the infant formula or a component, ingredient, constituent, or other feature of the infant formula, has, or may have, a health effect; “Health effect” means an effect on the human body, including an effect on one or more of the following: growth and development; physical performance; mental performance; a biochemical process or outcome; a physiological process or outcome; a functional process or outcome. In other words, health claims are prohibited including nutrient function claims, other function claims, and implied health claims. Examples are "Zinc helps in physical development", "Clinically proven", "Expert Care", "Intelligent", etc.
- A claim which directly or indirectly compares the infant formula, or a component, ingredient, constituent, or other feature of the infant formula, to breast milk;
- Any of the following prohibited matters:
  - A pictorial, graphic, or symbolic representation of an infant or infants (whether or not accompanied by text);
  - A pictorial, graphic, or symbolic representation of a pregnant woman or nursing woman (whether or not accompanied by text);
  - A word like “humanized” or “maternalized”, or words of similar import;
  - A claim which directly or indirectly idealizes the use or effect of the infant formula. Example of idealization claims: A representation that suggests or implies that the use or consumption of the infant milk formula results in exaggerated health or other effects.
- Nutrition claims with respect to energy, carbohydrate and nutrients listed under Regulation 252(3), i.e., Energy, Carbohydrate, Protein, Fat, Vitamin A, Vitamin D, Vitamin C, Vitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Folic acid, Pantothenic acid, Vitamin B12, Vitamin K1, Vitamin H, Vitamin E, Sodium, Potassium, Chloride, Calcium, Phosphorus, Magnesium, Iron, Iodine, Copper, Zinc, Manganese, Selenium. Examples of prohibited nutrition claims are: “Contains vitamin D”, “Contains essential nutrients”, “Added with vitamins and minerals”, and “Enriched with iron”.
- Where the infant formula contains isolated amino acids and optional ingredients, a claim which states, suggests, or implies that the infant formula is enriched or fortified, or is an excellent source of these ingredients. Examples of prohibited text claims: “Excellent source of DHA”, “25% higher in DHA”, “High in nucleotides”, “Enriched with nucleotides”.
No written, pictorial, or other descriptive matter appearing on or attached to, or supplied or displayed with food is to include the word “pure”, or any word of the same significance, in relation to food unless the food is free from other added substances or is of the composition, strength, and quality required under these Regulations.
Not include the word “organic”, or any word of the same significance, in relation to food unless the food is certified as organic under an inspection and certification system that complies with section 6.3 of the Codex Guidelines for the Production, Processing, Labelling, and Marketing of Organically Produced Foods, GL 32-1999; or that substantially complies with the Codex Guidelines mentioned and is acceptable to the Director-General as being a suitable system for the certification of organic food.

Young Child Formula [4][7]

No written, pictorial, or other descriptive matter appearing on or attached to, or supplied or displayed with food is to include any claim or suggestion whether in the form of a statement, word, brand, picture, or mark purporting to indicate the nature, stability, quantity, strength, purity, composition, weight, origin, age, effects, or proportion of food or its ingredients that is false, misleading or deceptive, or is likely to create an erroneous impression regarding the value, merit or safety of the food. Signs and symbols may sometimes be used in a manner that is false, misleading, or deceptive to create an erroneous impression regarding the value, merit, and safety of the food.
No claim or suggestion in relation to food that implies (i) the food has therapeutic or prophylactic action; (ii) the food will prevent, alleviate, or cure any disease or condition affecting the human body; or (iii) that health or an improved physical condition may be achieved by consuming the food.
No claim or suggestion that may be interpreted as advice of a medical nature from any person whatsoever.
No written, pictorial, or other descriptive matter appearing on or attached to, or supplied or displayed with food is to include the word “pure”, or any word of the same significance, in relation to food unless the food is free from other added substances or is of the composition, strength, and quality required under these Regulations.
Not include the word “organic”, or any word of the same significance, in relation to food unless the food is certified as organic under an inspection and certification system that complies with section 6.3 of the Codex Guidelines for the Production, Processing, Labelling, and Marketing of Organically Produced Foods, GL 32-1999; or that substantially complies with the Codex Guidelines mentioned and is acceptable to the Director-General as being a suitable system for the certification of organic food.
No package of a special purpose food that contains carbohydrates shall be labeled with the words “sugarless” or “sugar-free” or any words of similar meaning.

6.2 Nutritional Claims

6.2.1 Permitted Claims

Infant Formula and Follow-up Formula [1][2]

Claims on the addition of hydrolyzed milk protein or whey protein in infant formula are allowed, and their presence must be clearly disclosed under the statement of ingredients on the product label. Such infant formula may carry the following claims:

“Contains partially hydrolyzed whey protein”
“Added with extensively hydrolyzed protein”

Only for infant formula from protein sources other than soya protein isolates, and does not contain lactose, claims on the absence of lactose (e.g. Lactose-free, Low lactose) are allowed provided that the following criteria are complied with:

The total lactose content is not greater than 10mg per 100kcal;
The exact amount of lactose in the product is declared under the nutrition information panel
on the label; and
A statement indicating the product is not suitable for infants with galactosemia. This statement must be in the same font size and prominence as the statement on the absence of lactose and in close proximity to it. Examples of acceptable claims are:
1. Lactose-free - Not suitable for infants with galactosemia
2. No lactose - Not suitable for infants with galactosemia
3. Zero lactose - Not suitable for infants with galactosemia

Claims such as "Lower lactose" and "Reduced lactose" are NOT permitted.

Claims with respect to the presence of ingredients listed under Regulation 252(5) and 252(6) are permitted under the conditions that the claims do not in any way imply that the infant formula is enriched, fortified, or is an excellent source of these ingredients. Examples of acceptable claims are "Contains DHA", and "With inulin". The list of ingredients listed under Regulation 252(5) and 252(6) are:

Essential amino acids in natural L forms: Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine
Nucleotides: Cytidine 5’-Monophosphate, Uridine 5’-Monophosphate, Adenosine 5'-Monophosphate, Guanosine 5’-Monophosphate, Inosine 5’-Monophosphate
Long-chain polyunsaturated fatty acids [including docosahexaenoic acid (DHA) and arachidonic acid (AA)]
Galactooligosaccharides (GOS)
Long-chain inulin
Oligofructose produced from inulin
Polydextrose
Bovine lactoferrin
Beta-palmitin
2’-fucosyllactose (2’-FL)
2’-fucosyllactose/difucosyllactose mixture that contains at least 75% (w/w) 2’-fucosyllactose and 5% (w/w) difucosyllactose
Lacto-N-neotetraose (LNnT)

Young Child Formula [3][4][5]

Claim based on the presence of a vitamin or a mineral or implying the presence of a vitamin or a mineral is permitted if the food contains at least one-sixth of the daily allowance as laid down in Table I for the relevant vitamin or mineral, per (i) 60g milk powder (full cream or skimmed) and food containing not less than 51% of milk powder or (ii) solid food not specified 120g.
Claim that the food is enriched, fortified, ennobled, vitaminized, or in any way implies that the article is an excellent source of one or more vitamins or minerals is permitted if the food contains not less than 50% of the daily allowance as laid down in Table I for the relevant vitamin or mineral, per 60g milk powder (full cream or skimmed) and food containing not less than 51% of milk powder.

Any statement claiming or implying that the article of food is a source of one or more vitamins or minerals is permitted if the food contains not less than 50% of the recommended daily allowance (Table I) and unless the recommendation is declared on the label.

6.2.2 Nutritional Claim Registration

6.3 Health Claims

6.3.1 Permitted Claims

Infant Formula and Follow-up Formula [1]

N/A. Health claims are not allowed for infant formula and follow-up formula (which falls under the definition of infant formula).

Young Child Formula [3][4][5]

There are allowed nutrient function claims and other health claims and their criteria, per reference quantity of (i) 60g milk powder (full cream or skimmed) and food containing not less than 51% of milk powder or (ii) solid food not specified 120g. They must not be truncated or reworded to deviate from the original intended meaning. These claims are permitted as they are about essential nutrients that have established their recommended intakes and/or are of nutritional importance; There is enough generally accepted scientific evidence to prove the suggested function or role of the nutrient as claimed; The claim enables the public to understand the information provided and its significance to their overall daily diet; The claim does not state or imply that the nutrient is for prevention or treatment of a disease.

Health Claims - Nutrient-specific diet-related health claims:

The health claims set out in the Fourteenth Schedule may be made if the food meets the corresponding criteria per reference quantity of (1) 60g milk powder (full cream or skimmed) and food containing not less than 51% milk powder or (ii) solid food not specified, and are approved by the Health Promotion Board (HPB) to carry the Healthier Choice Symbol (HCS). The HCS criteria for children's milk powder (1-3 years old) are less than or equal to 0.5g, less than or equal to 1.2g saturated fat, and more than or equal to 70mg per 100ml reconstituted according to the manufacturer's direction on the label. Added sugar must be declared in the Nutrition Information Panel.

6.3.2 Health Claim Registration

Infant Formula and Follow-up Formula [1]

N/A.

Young Child Formula

Applicants who wish to apply for a new health claim (except disease risk reduction claims) on their food product, may submit the completed application form attached with the relevant scientific papers for review. The application form can be downloaded from the SFA website.
The application shall be submitted to the Singapore Food Agency (SFA). The scientific evaluation of the new health claim would be conducted by the Advisory Committee on Evaluation of Health Claims. The Committee comprises members from academia and relevant public agencies like the Health Promotion Board and Health Sciences Authority [8].

Applications for use of new health claims (except disease risk reduction claims) should include the following information: [4]

Name and address of the applicant;
Identity of the nutrient, food constituent, food or food category, in respect of which the health claim is to be made and its characteristics;
A copy of independent peer-reviewed reports of human intervention studies (at least 5 but not more than 10, and preferably published in the last 10 years), which have been carried out regarding the health claim;
Where available, the official statements by recognized expert scientific bodies (for example, World Health Organisation and food authorities of major developed countries) that have been verified and validated over time regarding the health claim to be made;
A proposal for the wording of the health claim for which the application is intended, and the specific conditions for use;
Where appropriate, an indication of the information that should be regarded as proprietary accompanied by verifiable justification; and
A summary of the application.

No administration fee is mentioned by the SFA or regulation.

Upon receiving a new health claim application, SFA as the secretariat would conduct a preliminary screening to ensure that all documents received are in order, before forwarding to the Committee for evaluation. Subsequently, the opinions from the Committee will be gathered for consideration by SFA on the outcome of the evaluation. The evaluation process would take up to 9 months or longer, from the time the complete application documents are received from the applicant, depending on the complexity of the application.

Following that, claims of nutrient function in nature (i.e. describes the physiological role of nutrients in growth, development, and normal functions of the body), will be published in the Guide to Food Labelling and Advertisements, upon approval. However, claims that suggest an improvement in health and physical condition, or prevention of disease would have to be gazetted in the Singapore Food Regulations. The gazettal process would take another 6 to 9 months.

6.4 Other Notes or Requirements for Claims

Infant Formula and Follow-up Formula [2]

Some other examples of accepted and prohibited claims can be found in the Guidance Document on Labelling Requirements for Infant Formula issued by the Singapore Food Agency.

Young Child Formula [9]

No claim based on the presence of a vitamin or a mineral or implying the presence of a vitamin or a mineral in a food shall be made on the label unless the reference quantity for that food as laid down in Table II contains at least one-sixth of the daily allowance as laid down in Table I for the relevant vitamin or mineral.
No label shall claim that any article of food is enriched, fortified, ennobled, vitaminized or in any way imply that the article is an excellent source of one or more vitamins or minerals unless the reference quantity for that food as laid down in Table II contains not less than 50% of the daily allowance as laid down in Table I for the relevant vitamin or mineral.
Referring to Table II Regulation 11, the reference quantity for the food is 60 g, applied for milk powder (full cream or skimmed) and food containing not less than 51% milk powder.