Food Compliance
Intelligence & Solutions
Singapore Infant Formula Regulation
Sep 21, 2022
Jerry Wang / Sadie Shen
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CONTENTS

1. Definition & classification

In Singapore, infant formula falls under the scope of "processed food" and is regulated as "special purpose food". Under Regulation 252 of the Food Regulations, infant formula shall be any food described or sold as an alternative to human milk for feeding infants. It shall be prepared from the milk of cows or other animals or both or from other edible animal constituents, including fish, plants, and which have been proved suitable for infant feeding. Regulation 252 defines infants as a person not more than 12 months of age.

Some types of infant formula include soy formula, hydrolysed milk protein formula, whey protein formula, and milk formulas without lactose. All of the above shall be labelled to be formulated for infants 0 to 12 months of age. 

2. Competent authority

Competent authority

Responsibility

Singapore Food Agency (SFA)

  • Licensing and registration of traders

  • Inspection and sampling of imported products

  • Review of novel food safety assessment

  • Food regulation drafting

Accounting and Corporate Regulatory Authority (ACRA)

Registration and supervision of business entities

Singapore Customs

Customs declaration

3.  Market access approval

3.1 Pre-market assessment

SFA adopts a risk-based approach to food safety. High-risk food products, including infant formula, are usually placed under strict import control. These products require pre-market assessment, such as the submission of documentary proof and health certificates.

Importers must obtain documentary proof that the imported infant formulas come from establishments regulated by the overseas competent authorities (e.g., certified true copy of the manufacturer's license). Please refer to Import Requirements of Specific Food Products for more details.

3.2 Overseas trader registration

Importers must register with SFA before importing processed food to Singapore. Before that, companies shall register with ACRA to get a Unique Entity Number (UEN) and activate their UEN with Singapore Customs through TradeNet. Please refer to Licensing and Registration of Traders and Step-by-Step Guide for more details.

3.3 Inspection and sampling

All food consignments are subject to inspection. SFA collects samples during these inspections for laboratory analysis. Inspection items include microbiological, pesticides, drug residues, preservatives, contaminants, and additives. In addition to the inspection and sampling conducted by SFA, laboratory test reports are required for importers every six months to show that the infant formula is safe.

4. Product compliance

4.1 Product requirements

In addition to the requirements for essential and optional ingredients in infant formula specified in Regulation 252 of the Food Regulations, SFA stipulates additives and contaminants requirements.

Item

Provision

Essential ingredients

The Food Regulation 252 (2) (3) (4):

e.g., protein:

Infant formula shall contain 1.8-4 g protein per 100 kcal of intake with nutritional quality equivalent to that of casein or greater quantity of other protein in proportion to its nutritional quality.

Optional ingredients

The Food Regulation 252 (5) (6) (7):

e.g., Cytidine 5’-Monophosphate:

The total level of Cytidine 5’-Monophosphate shall not exceed 16 mg per 100 kcal.

Food additives

Table 3: Food Additives Permitted for Use in Infant Formula (Regulation 252):

e.g., Guar gum (INS NO. 412).

For specific information on food additives, please check Food Additives Search.

Contaminants

Please refer to the Calculation guide for Infant formula to conduct self-checking on the compliance of the nutritional composition of infant formulas.

4.2 Label

Firstly, infant formula products in Singapore must follow the general labelling requirements in the Food Regulations. Secondly, as infant formula falls under special purpose food, it is required to meet additional labelling requirements in Regulation 248 of the Food Regulations. Regulation 254 provides labelling requirements for infant formula.

Item

Provision

Mandatory requirements for processed food

The Food Regulation 5-11:

e.g., name or description of the food, statement of ingredients, net quantity of food in package, name and address of local food business, country of origin (only for imported food products), expiry date (for certain kinds of food including   infant formula).

Mandatory requirements for special purpose food

The Food Regulation 248:

e.g., every package of special purpose food, unless otherwise exempted, shall bear a label containing a nutrition information panel in the form specified in the "Twelfth Schedule" or in such other similar form as may be acceptable by the Director-General and adequate information to support any claim made for that food.

Mandatory requirements for infant formula

The Food Regulation 254:

e.g., every package of infant formula, other than infant milk formula, shall bear a label indicating the sources of protein.

Others

The Food Regulation 251:

No label or advertisement for infants' food, other than infant formula formulated for infants from birth to 6 months of age, shall state or imply that such food is suitable for infants of or below 6 months of age.

Please check industry guidance and frequently asked questions below for specific labelling requirements for infant formula:

Plus, the promotion, marketing and distribution of infant formula should comply with the requirements in the Code of Ethics on the Sale of Infant Foods in Singapore.