Indonesia Sets New Safety and Quality Requirements for Health Supplements

On September 18, 2023, Indonesia Food and Drug Administration (BPOM) released BPOM Regulation No. 24 of 2023 on Safety and Quality Requirements for Health Supplements, which came into force immediately after its promulgation, repealing BPOM Regulation No. 17 of 2019 on Health Supplement Quality Requirements. The new regulation specifies general requirements for the safety and quality of health supplements in the main body, and sets more detailed requirements in the appendixes.

General requirements 

To obtain the circulation permit, all locally-produced and imported health supplements must meet the safety and quality requirements stated in this regulation. Notably, both raw materials of health supplements and finished products shall meet the corresponding requirements in accordance with Indonesian Pharmacopoeia and/or Indonesian Herbal Pharmacopoeia.

For enterprises whose products have already obtained circulation permits, they shall ensure the compliance with this new regulation within two years after its promulgation. However, for the maximum limits of contaminants in the form of ethylene glycol and diethylene glycol can be exempted from the adjustment. Instead, they shall conform to Indonesian Pharmacopoeia.

Detailed requirements 

• Appendix 1: Health supplement added with raw materials that may contain pollutants and pose a risk to health.

11 kinds of health supplement products are listed in Appendix 1, owing to the potential risks of their raw materials. For these 11 products, the addition of the affected raw materials must adhere to the restrictions specified in appendix 1. For example, products containing Cayenne extract are in the list due to the existence of Benzylpiperazine (BZP). To achieve compliance, the BZP contents in these products must be undetectable.

• Appendix 2: Certain types of simplicia powder.

The appendix 2 lists 11 types simplicia powder as natural sources of active ingredients for health supplements, including bee pollen, black cumin seeds, basil seeds, chlorella, sea cucumber, cork fish, red yeast rice, royal jelly, spirulina, garlic bulbs, and psyllium husk.

• Appendix 3: Residue limits for solvents used to extract active ingredients from natural materials.

Water and alcohol can be used to extract active ingredients from natural materials. When using other solvents other than water listed in appendix 3, the maximum residue limits must be fulfilled.

• Appendix 4: Maximum usage of additives.

Appendix 4 lists the additives permitted in health supplements and specifies their usage restrictions, covering multiple types of additives such as colorants, sweeteners, preservatives, antioxidants, flavorings, defoamers, emulsifiers, coatings, stabilizers, solvents, etc.

• Appendix 5: Oral dosage forms and finished product's testing parameters.

Oral dosage forms encompass 14 different types, such as powders, tablets, pills, capsules, and gummies. Appendix 5 outlines the testing parameters of finished products in these 14 types. These parameters cover comprehensive aspects of product quality, including sensory requirements, water content, decomposition, dissolution, weight/volume uniformity, microbial contamination, heavy metal contamination, alcohol content, active ingredients, etc.

• Appendix 6: Certain claims for qualitative identification tests for medicinal chemicals, psychotropic substances, narcotics and/or addictive substances.

Three types of claims are listed in appendix 6, namely, male stamina, slimming/fat reduction/diet, as well as gym/fitness. For products with these claims, qualitative identification tests for certain substances are required.

• Appendix 7: Application form for health supplement reviews.

For products that are not covered by the safety and quality requirements stated in this regulation, enterprises are required to apply for official reviews from BPOM. The application form provided in appendix 7 must be completed in its entirety. Following the acceptance of the complete application form, BPOM will publish the review results within 85 working days.

For the English translation of this regulation, please feel free to contact us via food@chemlinked.com.