health supplement registration in Singapore

Key things to note when importing Health Supplements into Singapore


At the current moment, Health Supplements are not subjected to registration prior to importation. Notification is on a voluntary basis. There may be advantage for you to execute the notification of the health supplements from a commercial perspective and it is always to be pro-active to adapt to the existing regulations rather than to rush frantically to submit when announcement is made officially.

We share some key points to note for importing health supplements:

  1. We need to be sure that your product falls under the category of health supplement. In order to fulfill the definition of Health Supplement in the local context , assess the below question :
  2. Is your product used to supplement a diet, maintain, enhance and improve the healthy functions of the human body?
  3. Does your product contain one or more of the following or combination of the ingredients:
  4. Vitamins, minerals, amino acid, fatty acids, enzymes, probiotics, and other bioactive substances;
  5. Substances derived from natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates; and
  • Synthetic sources of ingredients mentioned in (i) and (ii).
  1. Your product dosage form should not be an injectable or eye drop.
  1. From safety and quality perspective, we need to ensure that the health supplement does not contain negative list of substances and meet the limits allowable for vitamins and minerals, heavy toxic metal, and microbial limits. The product is manufactured to a consistent quality meeting release requirements for specific dosage form and is stable throughout the proposed shelf life.  Please refer to below table for quick reference on the links for your compliance exercise :
Checklist Links:
Check for negative list of substances ASEAN-Guiding-Principles-for-Negative-List-HS-V4.0
Heavy metal limits

 

Arsenic  5 parts per million

Cadmium  0.3ppm

Lead        10ppm

Mercury  0.5ppm

Microbial limits ASEAN Guidelines on Limits of Contaminants for Health Supplements
TSE checklist ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Health Supplements
Vitamins and Mineral Limits ASEAN General Principles for Establishing Maximum Levels of Vitamins and Minerals in Health Supplements
Quality Standards Physical test parameters based on dosage forms

Testing requirements

Manufacturing standards

Labelling Standards Guideline for labelling standards
Stability and Shelf Life ASEAN Guidelines on Stability and Shelf-Life of Health Supplements

 

  1. Health supplement claims must not be labelled , advertised or promoted for treatment or prevention of any disease or related conditions. There are some general principles which we can follow:
  • We need to ensure that the claim is truthful and is simple to understand.
  • We need to ensure the claim is well substantiated from good-quality scientific evidence from human studies.
  • There should not be testimonials from health professionals .
  • Testimonials from individual must be genuine and validated with real person information.
  • The claims cannot exploit fear or discourage from medical advice.
  • There should be no reference to performance in studies ,anti-aging, sexual function and relationships , consumption, hormonal levels, blood sugar levels, claims of safety.
  • Refrain from using scientific data that the public cannot comprehend to exaggerate the efficacy of the product.
  • The advertising of the product should comply with Singapore Code of Advertising Practice (SCAP).

      Below are references to consider before affixing claims to your health supplement:

  1. List of Health Claims
  2. Claims substantiation Guidelines

 

We hope the above has been useful for you for importation of health supplements into Singapore.  If you need help to notify your health supplements, please feel free to check our service.  Share it with your peers who might need them!

 

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