Food Compliance
Intelligence & Solutions
Indonesia Health Supplement Regulation
Jun 28, 2024
Jerry Wang
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CONTENTS

1. Definition & classification 

As per BPOM Regulation No. 27 of 2022 on Control of the Importation of Drugs and Food into Indonesian Territory, health supplements are products intended to complement nutritional needs; maintain, enhance and/or improve health functions; have nutritional value and/or physiological effects; contain one or more ingredients in the form of vitamins, minerals, amino acids, and/or other non-plant ingredients that can be combined with plants.

2. Competent authority 

Competent authority

Responsibility

Badan Pengawas Obat dan Makanan (BPOM)

BPOM is responsible for protecting public health through the control of and supervision on food products, traditional medicine, cosmetics, pharmaceuticals, biopharmaceuticals, and health supplements. To be specific, BPOM is tasked to issue import permits for food products and oversee the distribution of food products in Indonesia.

3. Market access approval 

3.1 Distribution permit 

In Indonesia, in order to obtain the distribution permit of health supplements, business operators are required to register their products with BPOM. For imported products, the applicants shall be local importers. In principle, the distribution permit shall be valid for five years, and can be prolonged via re-registration. For the specific registration procedures and requirements, please refer to Criteria and Administration of Health Supplement Registration

3.2 Import permit 

To import health supplements into Indonesian territory, a SKI Border, i.e., an import permit from BPOM applied by local importers with circulation permit, shall be obtained. Each SKI Border is valid for one single importation only. Local importers shall finish the importation within seven days from the date of receiving SKI Border. For the specific application procedures and requirements, please refer to BPOM Regulation No. 27 of 2022 on Control of the Importation of Drugs and Food into Indonesian Territory.

4. Product compliance 

4.1 Product requirements 

The quality requirements for health supplements are specified in BPOM Regulation No. 24 of 2023 on Safety and Quality Requirements for Health Supplements, including the permitted auxiliary materials, the maximum limits of contaminants, the quality requirements for finished products, as well as the determination methods of active ingredients.

In addition, Annex 7 of Criteria and Administration of Health Supplement Registration provides the list of permitted vitamins, minerals, amino acids and other ingredients. Annex 8 lists the forbidden ingredients in health supplements.

4.2 Label 

The labeling requirements for health supplements are regulated by BPOM Regulation No.10 of 2024 on Labeling of Natural Medicines, Quasi Medicines and Health Supplements .

Besides, Indonesia will mandate halal certification for both local and imported foods and beverages since October 17, 2024, which required product labels to show halal or non-halal information. Please refer to Indonesia Halal Food Regulation for more details.

The use of claims for health supplements is guided by Regulation Number 19 of 2022 concerning Guidelines for Claiming Health Supplements. The Guidelines divide claims into three types, namely, general claim, functional claim, and disease risk reduction claim. Besides, the corresponding scope and examples are detailed. Furthermore, the Guidelines list the supporting documents for claims, and examples of permitted/forbidden claims.

Recommended resources:

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