Entering 2026, expectations for BPOM Indonesia registration are higher than before. Recent regulatory changes emphasize safety, documentation, and digital integration, particularly in cosmetics, food, supplements, and pharmaceuticals.
Instead of focusing only on approvals, BPOM now monitors product compliance throughout its entire lifecycle. This article explains the most relevant updates and how they affect businesses operating in Indonesia.
Key regulatory changes for BPOM Indonesia registration
BPOM Indonesia has issued several new regulations that change how businesses must approach product registration and compliance. These rules place greater responsibility on companies to ensure their products meet updated safety and quality standards.
Regulatory requirements for BPOM-regulated products
BPOM Regulation No. 25 of 2025 focuses on ingredient safety, documentation, and reformulation standards. While it was designed specifically for cosmetics, its implications also affect other regulated categories. All affected products must comply by October 3, 2026.
| Product Category | Key Regulatory Changes |
| Cosmetics | Stricter ingredient restrictions and banned substances Revised UV filter limits Enhanced safety and label documentation standards |
| Dietary Supplements | More robust ingredient safety documentation Mandatory reformulation checks for borderline claims or ingredients |
| Processed Food & Beverages | Additive and preservative reclassification Updated requirements for labeling and nutritional claims |
| Traditional Medicines | Required risk assessments for raw materials Harmonization with health supplement compliance expectations |
| OTC & Prescription Drugs | Expanded product variation categories Labeling updates, including shelf-life and usage clarity |
| Household Health Products | More detailed chemical content evaluations Inclusion in BPOM's OSS-based tracking and permit systems |
All companies must ensure their registered products meet these new standards before the deadline.
Risk-based licensing and OSS integration
BPOM Regulation No. 27 of 2025 links product registration directly to the OSS system. Licensing is now based on product risk and fully digital. While this change improves efficiency, it also requires businesses to be more precise in how they declare and submit their product data.
This regulation applies to:
- Drugs and raw pharmaceutical materials
- Traditional medicines and supplements
- Cosmetics and skincare products
- Processed food and beverages
- Household health products
For businesses, this integration means:
- All licensing and product registration is now digital and centralized
- Product categories must be accurately declared in OSS
- Any mismatch or missing documentation may cause delays
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The goal is to make the process faster and more transparent, but it also requires companies to be more careful with how they prepare and submit their data.
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Raw material risk assessment
BPOM Regulation No. 26 of 2025 introduces mandatory risk assessments for raw materials used in:
- Traditional medicines
- Health supplements
- Quasi-drugs
- Cosmetics
The regulation encourages companies to:
- Source ingredients from verified and traceable suppliers
- Provide scientific data to support the safety of new or imported materials
- Ensure raw materials meet BPOM's latest technical standards
This adds another layer of control, mainly on imported or less familiar ingredients.
How recent updates impact BPOM Indonesia registration
The shift in BPOM regulations signals a bigger change in how product safety and compliance are enforced. Businesses now need to be more proactive in managing both their registrations and product lifecycles.
For local manufacturers
These updates require manufacturers to be more detail-oriented, especially when handling reformulations and compliance documentation.
- Recheck formulations, especially for cosmetics, supplements, and traditional products
- Ensure accurate submission through BPOM's e-Notifikasi system, connected with OSS
- Promptly update BPOM if there are any changes in ingredients or labeling
For importers and global brands
Compliance now begins before the product even enters Indonesia's borders.
- A valid Business Identification Number (NIB) is required for OSS-linked registration
- Certain products need SKI (border clearance approval) before import release
- Imported ingredients must meet updated risk assessment and documentation standards
For all product owners
Maintaining compliance is now continuous, not a one-time event.
- Dossiers must include current, detailed safety evidence
- Consistent data across OSS and BPOM systems helps avoid delays and possible enforcement actions
Recent trends and regulatory focus on BPOM Indonesia registration
BPOM Indonesia registration has started taking a more active role in monitoring products, especially since the new regulations were introduced.
In 2025, BPOM took several enforcement actions, including:
- Removed several cosmetic products from the market due to banned ingredients
- Conducted surprise checks, including on online platforms
- Issued recalls for products that didn't match their registered formulas
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These actions show that registration is just the beginning. Businesses must also ensure their products remain compliant after they're approved. Furthermore, BPOM is also expected to continue focusing on ingredient safety, product accuracy, and digital tracking.
Simplify your BPOM Indonesia registration with Ascentium Indonesia
New regulation on BPOM Indonesia registration marks a shift toward continuous compliance and more transparent product oversight. For companies planning to enter or grow in Indonesia's market, staying aligned with these expectations is essential.
If you're unsure how to move forward, you don't have to do it alone.
Ascentium Indonesia supports businesses through every stage of the BPOM registration process. Our product registration services include:
- Assisting with product classification, documentation, and submission
- Ensuring compliance with the latest ingredient and safety standards
- Managing OSS-based business licensing integration
- Acting as your official local license holder for BPOM compliance
