In 2019, the Indonesian National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) issued Regulation No. 12 of 2019 concerning Contamination in Cosmetic Products (“Regulation 12/2019”). This regulation outlined contamination thresholds that must not be exceeded in cosmetics circulating in Indonesia, including limits for microbial, heavy metal, and chemical residues that may arise during manufacturing, storage, or due to impurities in raw materials.
However, to reflect current advancements in scientific methodology and regulatory enforcement, and to streamline industry compliance in line with global best practices, BPOM has enacted a new regulation—Regulation No. 16 of 2024 on Contamination Limits for Cosmetics Products (“Regulation 16/2024”)—which will officially come into effect on 18 September 2025, repealing Regulation 12/2019 in its entirety.
The updated regulatory framework under Regulation 16/2024 introduces enhanced clarity and flexibility for cosmetics manufacturers and importers in Indonesia, particularly in the area of contamination testing procedures and internal laboratory utilization. Regulation 16/2024 continues to apply to all businesses involved in the distribution of cosmetics in Indonesia. These include:
- Manufacturers of cosmetic products operating within Indonesia;
- Individuals or business entities operating within Indonesia that operate under production contracts with manufacturers of cosmetic products that also operate within Indonesia; or
- Importers operating within the cosmetics sector.
Given the importance of the abovementioned Contamination limits, particularly for Businesses that manufacture and/or import cosmetic products, this article from ET Consultant offers an elaboration of the various provisions that are set out under Regulation 16/2024, specifically as they relate to the following matters:
- Revised Contamination Limits;
- Clarified Testing Procedures;
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Revised Contamination Limits
In general, Regulation 16/2024 maintains the same three categories of contamination previously established under Regulation 12/2019—namely microbial, heavy metal, and chemical contamination. However, rather than breaking down each category into detailed components as was done in Regulation 12/2019, the new regulation revises the approach by introducing updated and consolidated definitions for each type of contamination, as described below:
Contamination Type | Remarks |
| Microbial | Contamination caused by microorganisms may endanger human health due to their harmful nature. |
| Heavy metal | Contamination involving metallic or metalloid elements characterized by high atomic mass and density, which are toxic and hazardous to human health. |
| Chemical | Contamination resulting from chemical substances or compounds that carry potential risks and may negatively impact human health. |
While Regulation 16/2024 does not introduce major changes to the specific contamination limits previously set out in the Appendix of Regulation 12/2019, it does revise and update the applicable threshold values specifically for chemical contamination, as detailed in the following provisions:
| Chemical Contaminations | Remarks on Contamination Types | Applicable Limit |
| 1,4-Dioxane | Cosmetics containing ingredients that are produced through the ethoxylation process, such as Sodium Laureth Sulfate or Polyethylene Glycol | Must not exceed 10 mg/kg or 10 mg/L |
| Acrylamide (*) | Cosmetics containing Polyacrylamide ingredients | Must not exceed 0.1 mg/kg for leave-on body care products and must not exceed 0.5 mg/kg for other types of preparations |
| Diethylene glycol (*) | – | Must not exceed 0.1% |
It should be noted that the types of chemical Contamination that are marked with asterisks (*) above did not previously feature under Regulation 12/2019.
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Clarified Testing Procedures
Under the previous framework of Regulation 12/2019, contamination testing was restricted solely to accredited external laboratories. In contrast, Regulation 16/2024 now permits such testing to be conducted within the internal laboratories of cosmetics manufacturers, provided these laboratories are certified under Good Cosmetics Manufacturing Practices (Cara Pembuatan Kosmetika yang Baik – “CPKB”) or demonstrate compliance with relevant CPKB requirements.
In addition, the updated framework requires that all documentation outlining the results of contamination testing must be prepared in accordance with BPOM Regulation No. 17 of 2023 (“Regulation 17/2023”) concerning Guidelines for Product Information Documents (Dokumen Informasi Produk – “DIP”). According to Regulation 17/2023, the DIP must consist of the following four core components:
- Administrative documents;
- Data on the quality and safety of cosmetics materials;
- Data on the quality of cosmetics products; and
- Data on the safety and benefits of cosmetic products.
Conclusion
The enactment of Regulation 16/2024 marks a significant regulatory shift for the cosmetics industry in Indonesia, reinforcing BPOM’s commitment to safeguarding public health while also aligning national standards with global best practices. Although the core contamination categories and most limit values remain consistent with the previous regime under Regulation 12/2019, the introduction of updated chemical contamination thresholds and the recognition of new contaminant types signal a more refined and proactive approach to product safety.
One of the most pivotal changes under Regulation 16/2024 is the authorization of in-house contamination testing within CPKB-compliant laboratories. This move not only enhances testing efficiency and turnaround times but also empowers manufacturers to maintain stricter control over product quality through their internal quality management systems. Nonetheless, such testing must now be thoroughly documented in accordance with the Product Information Document (DIP) framework under Regulation 17/2023, further emphasizing BPOM’s push for greater transparency and accountability.
With the regulation set to take effect on 18 September 2025, manufacturers, importers, and brand holders are strongly encouraged to review their existing compliance structures, upgrade laboratory operations, and ensure all supporting documentation—including contamination test results and DIP—is fully aligned with BPOM’s updated expectations. Non-compliance may result in administrative sanctions, including the suspension of product notification or restrictions on distribution.
To support this transition, ET Consultant stands ready as your strategic compliance partner. Our team of regulatory experts, legal consultants, and technical specialists provides tailored assistance for aligning contamination thresholds under Regulation 16/2024, setting up CPKB-compliant in-house laboratories, compiling and reviewing DIP dossiers, managing product notification with BPOM, and facilitating regulatory engagement with the authorities. We are committed to ensuring that your operations remain compliant, audit-ready, and competitive in the evolving cosmetics market. Contact ET Consultant today to begin your compliance preparation ahead of the 2025 deadline—because in regulatory matters, timing, accuracy, and strategy make all the difference.
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ET Consultant is a Business Consultant and Legal Consultant Expert that provides support for local and multinational clients to start and manage their business operations in Indonesia. ET Consultant specializes in Business Incorporation, Licensing & Legal, Accounting & Taxes, Immigration, and Advisory Services.
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