Indonesia Unveils Legislative Plan for Food and Health Supplement Regulations in 2025

On April 28, 2025, the Indonesian Food and Drug Authority (BPOM) released Decree No. 278 of 2025 on the Program for the Preparation of Laws and Regulations in 2025. This roadmap prioritizes the development and revision of regulations aimed at enhancing safety, transparency, and competitiveness across the food, supplements, cosmetics, and pharmaceutical sectors. This update specifically focuses on the food and health supplements segment, addressing key areas such as product labeling, registration, importation, distribution, recalls, and more. The main initiatives are summarized below:

No.	Regulation title	Purpose	Target	Legislative direction
1	Draft of BPOM Regulation on the Inclusion of Information on the Origin of Materials in Product Information and/or Labels	For business operators, this regulation provides a legal basis for including information on the origin of materials prior to product distribution in Indonesia. For regulatory officers, it serves as a legal instrument to ensure that labeling of material origins complies with BPOM standards. Encourage businesses to disclose material origin information in line with BPOM standards, thereby enhancing the economic value and competitiveness of domestic products.	All business actors in the pharmaceutical and food sector who produce and/or import pharmaceutical and food products for distribution in Indonesia.	This regulation aims to ensure legal certainty and support fair trade in the competitive pharmaceutical and food markets. It mandates compliance with standards and/or requirements related to safety, efficacy, and quality, including the provision of complete, objective, and non-misleading information on ingredient origins. This helps prevent public health risks arising from the consumption of incorrect or inappropriate products.
2	Revision of BPOM Regulation No. 10 of 2022 on Guidelines for In Vivo Preclinical Toxicity Testing	Update the annex in order to reflect advances in science and technology Accommodate new methodologies, including those aligned with the 3Rs principles—Replacement, Reduction, and Refinement—in the use of test animals.	Business actors in the field of medicine and food and/or research institutions BPOM evaluators	Incorporation of updated and new methods for in vivo preclinical toxicity testing. Revision and enhancement of technical explanations.
3	Draft BPOM Regulation on Risk Assessment of the Use of Raw Materials in Natural Medicines, Health Supplements, Quasi-Drugs and Certain Cosmetic Preparations	Protect the public from the circulation of natural medicines and health supplements that fail to meet safety and quality standards and may pose health risks Establish provisions for the risk assessment of additional materials used in certain formulations	Business actors in the field of natural medicine BPOM officers	To serve as guidelines for conducting risk assessments on raw materials used in natural medicines, health supplements, quasi-drugs, and certain cosmetic products, in accordance with Article 406 of Government Regulation No. 28 of 2024.
4	Revision of BPOM Regulation No. 19 of 2021 on Guidelines for Follow-up on the Results of Supervision of Traditional Medicines, Quasi-Drugs, Health Supplements, and Cosmetics	Update procedures for follow-up actions based on the results of supervision of health supplements (SK), in response to current issues such as the EG/DEG contamination case, product phase-outs, depletion of old packaging stock, and product withdrawal and destruction. Align with newly issued regulations, including the Health Law, updated oversight provisions for the distribution of SK, online distribution rules, and the implementation of 2D barcodes.	BPOM officers Business actors in the field of natural medicines, quasi medicines, health supplements, and cosmetics	Targeted at supervisory officers at production and distribution facilities. Covers labeling, promotion/advertising, and adverse event monitoring for natural medicines, quasi-drugs, health supplements, and cosmetics. Includes provisions for administrative sanctions and transitional/validity periods. The annex outlines the introduction, classification of findings, and follow-up actions resulting from the supervision of these products.
5	Draft BPOM Regulation on the Second Amendment to the BPOM Regulation No. 27 of 2022 on Supervision of the Importation of Drugs and Food into the Territory of Indonesia	Protect the public from drugs and food products that do not meet safety, efficacy, and quality standards. Update regulatory provisions in line with the operation of free trade zones, free ports (including special economic zones and bonded storage areas), and the Sabang Free Trade and Free Port Zone (KPBPB Sabang). Serve as a guideline for BPOM officers in supervising the importation of drugs and food in Indonesia.	Business actors in the field of drugs and food BPOM officers Related ministries/non-ministries	Exemption from Border/Post-Border SKI (Import Notification Letter) requirements for imports of drugs and food into bonded storage areas, free trade zones, and free ports, provided the products are not intended for distribution within Indonesia. Exemption from Border/Post-Border SKI requirements for imports into KPBPB Sabang, if distribution is limited to within the Sabang area to meet local needs. Reaffirmation that the supervision of drug and food imports will continue to follow applicable laws and regulations. Imports from KPBPB Sabang into the Indonesian customs territory will be treated as regular import activities and must comply with national trade regulations, including SKI requirements.
6	Revision of BPOM Regulation No. 26 of 2021 on Nutritional Value Information on Processed Food Labels	Provide consumers with the necessary information to make informed food choices based on their nutritional needs, by requiring nutritional information on processed food labels. Serve as a guideline for business actors in presenting nutritional information on processed food labels, including front-of-pack labeling. Serve as a reference for food supervisors in monitoring the accuracy and compliance of nutritional information on processed food labels, including front-of-pack labeling.	Food business actors Food supervisors	Establish regulations governing the inclusion of nutritional information on processed food labels.
7	BPOM Regulation on Amendments to BPOM Regulation No. 27 of 2021 on Requirements for Hermetically Packaged Low Acid Processed Foods	Provide a legal basis for the requirements governing hermetically packaged low-acid processed foods, offering a streamlined pathway for business actors who use barrier technology with specific criteria that inhibit the growth and/or enable the inactivation of Clostridium botulinum spores.	Food business actors Food supervisors	Establish legal provisions for defining the criteria under which barrier technology can be used to inhibit the growth and/or inactivate Clostridium botulinum spores in hermetically packaged low-acid foods, serving as an alternative to challenge testing for demonstrating compliance with commercial sterility requirements.
8	BPOM Regulation on Amendments to BPOM Regulation No. 23 of 2023 on Processed Food Registration	Realign processed food registration procedures with recent policy developments. Protect the public from processed food products that do not meet safety, quality, nutritional, and labeling standards.	Government Business Actors Society	Establish regulations on processed food registration as a reference for government authorities, the public, and especially business actors.
9	BPOM Regulation on Amendments to BPOM Regulation No. 10 of 2023 on the Implementation of Food PMR in Production Facilities	To provide a legal basis for the implementation of a food safety risk management (PMR) program in processed food production facilities.	Business actors Food supervisors	Serve as a reference for: Food supervisors in overseeing the implementation of PMR by business actors. Business actors in applying PMR within processed food production facilities.
10	Draft Revision of BPOM Regulation No. 22 of 2021 on Procedures for Issuing Permits for the Implementation of Good Processed Food Production Methods	Provide a legal basis for the provisions governing the submission of Good Processed Food Production Method (IP CPPOB) documents for both pre-market evaluation (registration) and post-market evaluation (certification), serving as a reference for business actors and relevant stakeholders.	Processed food business actors Processed food supervisors	Implementation of a grace period for IP CPPOB compliance, as only approximately 30% of processed food production facilities currently possess an IP CPPOB. Regulations outlining the authority and mechanisms for the revocation or cancellation of IP CPPOB. Provisions for rejecting applications from businesses that have violated food safety regulations or are undergoing sanction processes. Clarification of the process scope related to Non-Tax State Revenue (PNBP) tariffs. Explanation of the distinction between permits and certifications in relation to PNBP tariffs.
11	Draft BPOM Regulation on the Implementation of the Processed Food Safety and Quality Assurance System at Distribution Facilities (Revision of BPOM Regulation No. 21 of 2021 on the Implementation of the Processed Food Safety and Quality Assurance System at Distribution Facilities)	Expand the scope of application and certification for the Processed Food Safety and Quality Assurance System (SMKPO) in line with current trade trends. Simplify the SMKPO certification process for business actors by providing up-to-date procedural information.	Business actors Food supervisors	Serve as a guideline for: Business actors on proper distribution practices for processed food. Business actors and officials involved in the SMKPO certification process, including applicable sanctions for non-compliance. Supervisory personnel conducting inspections of processed food distribution facilities.
12	Draft BPOM Regulation on Guidelines for Follow-up of Processed Food Supervision Results	Ensure order and consistency among BPOM officers in carrying out follow-up actions based on food supervision results. Ensure that business actors receive fair treatment through the consistent application of follow-up measures.	Business actors Food supervisors	Serve as a guideline for: Supervisory officers in implementing follow-up actions and imposing sanctions based on food supervision outcomes. Business actors in accessing transparent information regarding the supervision and enforcement mechanism.
13	Draft BPOM Regulation on Withdrawal and Destruction of Food from Circulation	Protect the public. Serve as a reference for the follow-up and supervision of products that do not comply with regulatory requirements. Guide the implementation of food product destruction as part of the withdrawal process.	Business actors Food supervisors	Serve as a guideline for: Business actors in withdrawing and destroying food products that do not meet regulatory standards. Supervisory officers in conducting follow-up actions and oversight of non-compliant processed food products.
14	Draft Revision of BPOM Regulation No. 32 of 2020 on Amendments to BPOM Regulation No. 8 of 2020 on Supervision of Drugs and Foods Distributed Online	Establish comprehensive regulations that outline the mechanisms for monitoring the online distribution of drugs and food, providing a legal framework for business actors engaged in online sales. Serve as a legal basis for BPOM officers in supervising online drug and food distribution to ensure compliance with safety, efficacy, and quality standards. Protect the public from health risks associated with drugs and food distributed online that do not meet regulatory requirements.	All business actors in the field of drug and food who produce and/or import products to be distributed online in Indonesia.	Provide legal certainty for business actors in the pharmaceutical and food sectors engaging in online distribution, as well as for consumers. Developed with an adaptive approach that aligns with current trends in product types, digital platforms, and the evolving technologies used in online distribution.