Food Supplement Registration in Singapore

Regulatory Authority Health Science Authority Regulatory Website

https://www.hsa.gov.sg/

6-12 Months

5 Years

A health supplement is a substance that is intended to support, maintain, enhance, and improve the body’s natural processes in addition to being used as a diet supplement. It cannot be a sterile preparation or an injectable, such as eyedrops or injections. It can’t be a part of a diet or food plan.

Additionally, a health supplement needs to include one or more of the following components, or a mix of them:

a. Probiotics, vitamins, minerals, fatty acids, amino acids, enzymes, and other bioactive materials;

b. Components obtained from natural sources, such as extracts, isolates, and concentrations of animal, mineral, and plant components;

c. Ingredients from synthetic sources.

A dietary supplement needs to be taken in tiny dosages using the following dosing forms:

• Soft gel Capsules
• Liquids,
• Tablets
• Syrups

The HSA does not require authorization or licenses for the importing, production, or sale of health supplements. The HSA forbids adding prescription drugs, like steroids, to dietary supplements. 

Strict limitations on hazardous heavy metals in these items are also set by HSA. Before supplying health supplements into Singapore, dealers (importers, producers, wholesale dealers, and sellers) have an obligation to make sure that their products are safe and do not violate any regulations.

Documents Required for Food Supplement Registration in Singapore

• A copy of the completed form Certificate of Analysis (with relevant test parameters, specifications, and references) Manufacturer’s license or certification
• Final product label or artwork (with batch number and expiration date located)
•  Product flyer (if available)
• Toxic heavy metal and microbiological limit test report from a laboratory (with technique reference)* Laboratory test report for screening for toxins (based on product type)* If applicable, Transmissible Spongiform Encephalopathy (TSE)
• Form to Request a Website Address or QR Code for Packaged Goods
• Form 11 KB for product linkage (if appropriate)
• A list of the documentation needed for voluntary notification.