Singapore Infant Formula Regulation

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 Importer 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.

3.2 Import permit

For each shipment entering Singapore, importers must apply for an import permit through TradeNet. The application requires submission of relevant supporting documents and payment of applicable fees. Detailed requirements can be found in import permit application.

It shall be noted that infant formula products (age 0-12 months) are classified as higher-risk products and are subject to the Regulated Source Programme. For these products, importers must ensure that they are imported from establishments regulated by the competent authorities of the exporting country or region with an acceptable quality assurance programme (e.g. HACCP and GMP). And when applying for import permits for these products, the importers shall submit additional supporting documents including the regulated establishment proof (one time submission), health certificates (every consignment) and quality control reports on chemical and microbiological test (once every 6 months) for SFA review.

Infant formula imported from Malaysia are subject to the enhanced Regulated Source Programme, under which the products must originate from Malaysian establishments registered with the Malaysian Ministry of Health.

Further requirements about products under the Regulated Source Programme can be found in the Import Requirements for Food & Food Products.

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 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.
Contaminants	Microbiological standards for ready-to-eat food Heavy metals Mycotoxins and Marine biotoxins Veterinary drug residues Food with Maximum Amounts of Pesticides Other incidental constituents

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.

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Covered Countries

China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand etc.

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Tags: Singapore Infant Formula Labeling Importation Contaminants Food Ingredients