Supplements
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1. Why us?
Navigating the regulatory landscape for Supplements in Singapore can be complex, but with our deep understanding of the local regulatory requirements, we make the process seamless for you. We provide expert consultation and guide you through every step of the registration process, ensuring that your products meet all the necessary compliance standards for the Singapore market.
2.What is a Supplement?
A health supplement is a product that is used to supplement a diet and to support or maintain, enhance and improve the healthy functions of the human body. It cannot be an injectable or a preparation that needs to be sterile, such as injections and eyedrops. It cannot be an item of a meal or diet.
What is Not Considered a Supplement?
Food products that aids health in general may not be classified as a supplement and is regulated under Singapore Food Agency (SFA) instead.
Not Sure if Your Product Qualifies?
Contact us for a free consultation, and we'll help you clarify whether your product is considered a cosmetic under Singapore's regulations. Our regulatory experts will guide you through product classification, notification requirements, and compliance documentation, helping you get to market faster—with confidence.
3. Voluntary notification of health supplements
Health supplements are not subject to approvals and licensing by HSA for their importation, manufacture and sales. HSA prohibits the addition of medicinal ingredients such as steroids in health supplements. HSA also sets strict limits on toxic heavy metals in these products.
Dealers may voluntarily notify HSA of their health supplements supplied in Singapore. Companies must provide HSA with the relevant documents to demonstrate that their products meet the necessary safety and quality standards.
4. Prohibitions
There are many substances which are not allowed in a supplement. There has been many
cases of recall which may affect brand reputation. Hence it is important to pre-check in order to protect branding.
Toxic heavy metal limit will be checked locally, per batch, before release for sale
| Heavy metal | Permissible limits |
|---|---|
| Arsenic | 5 parts per million (ppm) |
| Cadmium | 0.3 ppm |
| Lead | 10 ppm |
| Mercury | 0.5 ppm |
Toxic heavy metal limit will be checked locally, per batch, before release for sale.
Microbial limits
Your product must not exceed the following microbial limits:
| Microbe | Microbial count (colony-forming units (CFU) per g or ml of product) |
|---|---|
| Total aerobic microbial count | Not more than 105 |
| Yeast and mould | Not more than 5 x 102 |
| Escherichia coli, salmonellae and staphylococcus aureus | Absent |
Others:
Diethylene glycol and ethylene glycol limits
Oral liquid CHPs must not exceed the following diethylene glycol and ethylene glycol limits:
Substance Limits
| Substance | Quantity (by weight) |
|---|---|
| Diethylene glycol | 1000 parts per million (ppm) |
| Ethylene glycol | 1000 ppm |
In general, the vitamin and mineral contents have limitations to be classified as a supplement and this limitations apply across SEA.
Vitamin and mineral limits
Vitamin limits
The following table specifies the limits of vitamins in health supplements for the general adult population.
| Nutrient | Maximum Daily Limit |
|---|---|
| Biotin | 0.9 mg |
| Folic acid | 0.9 mg |
| Nicotinamide | 450 mg |
| Nicotinic acid | 15 mg |
| Vitamin A (Retinol) | 1.5 mg (5000 IU) |
| Vitamin B1 | 100 mg |
| Vitamin B2 | 40 mg |
| Vitamin B5 (Pantothenic acid) | 200 mg |
| Vitamin B6 | 100 mg |
| Vitamin B12 | 0.6 mg |
| Vitamin C | 1000 mg |
| Vitamin D | 0.025 mg (1000 IU) |
| Vitamin E | 536 mg (800 IU) |
| Vitamin K1 / K2 | 0.12 mg |
Mineral limits
The following table specifies the limits of minerals in health supplements for the general adult population.
| Nutrient | Maximum Daily Limit |
|---|---|
| Boron | 6.4 mg |
| Calcium | 1200 mg |
| Chromium | 0.5 mg |
| Copper | 2 mg |
| Iodine | 0.15 mg |
| Iron | 15 mg* |
| Magnesium | 350 mg |
| Manganese | 3.5 mg |
| Molybdenum | 0.36 mg |
| Phosphorus | 800 mg |
| Selenium | 0.2 mg |
| Zinc | 15 mg |
Higher levels of vitamins and minerals for specified group of patients must be justified with data that will be checked locally. Some examples of successful allowance for higher limit tolerance:
Zinc forpatients with wounds or metabolic conditions
Vitamin B2 for patients with certain genetic or metabolic disorders
Folic acid for pregnant women to prevent against recurrence of neural tube defects or for patients with folic acid deficiency
Iron for patients with low blood haemoglobin level
Minimum technical files to be provided:
Product stability and shelf life
Storage conditions and distribution practices
Manufacturing, packaging and assembly conditions
The following manufacturing standards are considered acceptable:
• Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice for Medicinal Products
• World Health Organisation (WHO) Good Manufacturing Practices (GMP) for Pharmaceutical Products
• ASEAN Guidelines on Good Manufacturing Practice (GMP) for Health Supplements
• ASEAN Guidelines on Good Manufacturing Practice (GMP) for Traditional Medicines
• United States Food and Drug Administration (US FDA) Current Good Manufacturing Practice (cGMP) for Dietary Supplements • International Organisation for Standardisation (ISO) - Food Safety Management (ISO 22000)*
• Food Safety System Certification (FSSC) 22000*
• Hazard Analysis Critical Control Point (HACCP) Systems*
* These are certification standards for food safety management systems which are considered suitable for HS and TM if the product is regulated under Food Laws in the country of manufacture and the overseas manufacturers hold valid manufacturer’s licence issued by the overseas regulatory authorities. Additionally, for manufacturers that are certified to HACCP standard, the manufacturers should have proper procedures in place to manage feedback and recall activities.
Labelling
Labelling can have multiple languages, however, pertinent information must be found in English.
Prohibited diseases and conditions
Supplement products must not claim to prevent, treat, or cure any of the following 19 diseases or conditions, whether directly or indirectly:
Blindness
Cancer
Cataract
Drug addiction
Deafness
Diabetes
Epilepsy or fits
Hypertension
Insanity
Kidney diseases
Leprosy
Menstrual disorder
Paralysis
Tuberculosis
Sexual function
Infertility
Impotency
Frigidity
Conception and pregnanc
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