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On April 28, 2025, the Indonesian Food and Drug Supervisory Agency (BPOM) released the 2025 legislative plan, which includes finalized and draft amendments as well as new regulations. 1 Regulations related to cosmetics are summarized in the following table and cover areas such as cosmetic notification, ingredient requirements, labeling, testing, production, and both online and offline distribution.
No. | Regulation | Latest Version Effective Date/Latest Draft Release Date | Revision Direction |
1 | Draft BPOM Regulation concerning the Inclusion of Ingredient Origin Information in Product Information and/or Labels (intended to replace the BPOM Head Regulation No. HK.03.1.23.06.10.5166 of 2010 concerning the Inclusion of Information on the Origin of Certain Ingredients, Alcohol Concentration and Expiry Dates on the Labeling/Labels of Drugs, Traditional Medicines, Food Supplements and Food) | July 5, 2010 | The regulatory enhancement regarding the inclusion of ingredient origin information extends beyond drug commodities and biological products to also encompass natural medicines, quasi-drugs, health supplements, cosmetics, and processed foods. These revisions are consolidated with the aim of simplifying existing regulations. |
2 | Amendments to BPOM Regulation No. 12 of 2023 concerning the Supervision on Manufacture and Circulation of Cosmetics
| March 28, 2023 | Several provisions regarding cosmetic supervision require adjustment to align with the latest developments in the cosmetic sector. |
3 | March 8, 2025 (Draft) | The growing trend of cosmetic efficacy claims shared on social media—particularly through trials conducted by influencers—underscores the urgent need for regulations governing public participation in the oversight of cosmetic product circulation. In response, the immediate development of relevant regulatory provisions is deemed necessary. | |
4 | Draft Amendments to BPOM Regulation concerning Certification of Cosmetic Good Manufacturing Practices | December 11, 2024 (Draft) | Provisions governing the requirements for approving the shared use of cosmetic production facilities with quasi-drugs need to be established. |
5 | Draft Amendments to BPOM Regulation concerning Procedures for Submitting Cosmetic Notification | December 9, 2024 (Draft) | Several provisions—such as response time clarification, inclusion of ingredient content levels in the notification template, and brand license agreement requirements—need to be updated to align with the latest developments in the cosmetics sector. |
6 | Draft Amendments to BPOM Regulation concerning Procedures for Approval of Clinical Trials (Cosmetic Ingredients) | November 4, 2024 (Draft) | The development of technology and science in the cosmetics sector is dynamic and innovative, leading to increased research activities in the field.
There is a need for cosmetic clinical trial guidelines to serve as a reference for BPOM officers in evaluating supporting test data, as well as for business actors in planning and conducting cosmetic clinical trials. |
7 | Draft BPOM Regulation concerning Technical Requirements for Cosmetic Ingredients | March 1, 2024 (Draft) | To expedite the implementation of updates on prohibited ingredients agreed upon during ASEAN Sessions, it is necessary to introduce a provision allowing amendments to the list of prohibited ingredients to be made through a Decree of BPOM Head.
Several provisions must be updated to reflect advancements in cosmetic science and technology, and therefore require revision. |
8 | Amendments to BPOM Regulation concerning Guidelines for Preclinical In Vivo Toxicity Testing | November 4, 2024 (Draft) | Scientific evidence of safety can be demonstrated through preclinical toxicity testing on laboratory animals to ensure that drugs and food products meet safety standards.
To support innovation and the development of drug and food products, updated toxicity testing guidelines are essential. |
9 | November 11, 2024 (Draft) | In 2022, cases involving EG-DEG contamination in excipients used in certain preparations highlighted the need for stricter oversight.
As a follow-up to the Government Regulation implementing Law No. 17 of 2023 on Health—specifically in reference to letters (a) and (b), and to enforce Article 389 paragraphs (4) and (5)—it is necessary to establish a BPOM regulation concerning pharmaceutical ingredients used in certain preparations of natural medicine ingredients, health supplements, quasi-drugs, and cosmetics. | |
10 | December 11, 2024 (Draft) | In light of the EG/DEG contamination cases and recent supervisory findings requiring follow-up actions that were not addressed under previous regulations, and following the issuance of BPOM Regulation No. 16 of 2023 on the Supervision of the Distribution of Traditional Medicines, Quasi-Drugs, and Health Supplements, as well as BPOM Regulation No. 12 of 2023 concerning Supervision on Manufacture and Circulation of Cosmetics, regulatory adjustments are necessary. | |
11 | Draft BPOM Regulation concerning the Second Amendment to the BPOM Regulation No. 27 of 2022 concerning Supervision on the Entry of Drugs and Food into the Territory of Indonesia | December 8, 2023 | Input has been received regarding the importation of drugs and food into free trade zones, free ports, special economic zones, bonded storage areas, and specifically the Sabang Free Trade Zone and Free Port.
Such importation is intended solely for non-distribution within the Indonesian mainland or to meet the specific needs of the population within the BPKS Sabang area.
This initiative serves as a long-term response to the request from the Indonesian Duty Free Shop Association (ATBBI) and a consultation held with BPKS Sabang in 2024. |
12 | Revised Draft BPOM Regulation concerning Control of Drug and Food Online Distribution | May, 2025 (Draft) | This regulation needs to be harmonized with other relevant regulations, including: a. Ministry of Health Regulation No. 14 of 2021 on Standards for Business Activities and Products under the Risk-Based Business Licensing System in the Health Sector; b. Ministry of Trade Regulation No. 31 of 2023 on Business Licensing, Advertising, Development, and Supervision of E-Commerce. |
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