May 08, 2025
Indonesia, Southeast Asia’s largest economy, is witnessing rapid growth in its cosmetics and personal care market. For global cosmetic brands, understanding the regulatory framework set by the National Agency of Drug and Food Control (BPOM) is essential for successful market entry and sustained compliance.
This guide outlines the key 2025 BPOM regulations, product classifications, labeling requirements, and compliance obligations aligned with ASEAN standards.
Regulatory Framework Governing Cosmetics in Indonesia
Indonesia’s cosmetic sector is regulated to ensure consumer safety and product quality. The main regulations include:
- Law No. 36/2009 on Health
- Government Regulation No. 72/1998 on Cosmetic Safety and Quality
- BPOM Regulation No. 18/2024 on Labeling, Promotion, and Advertising
BPOM enforces strict standards on formulation safety, ingredient transparency, labeling, and claims substantiation to ensure all products on the market are safe and effective.
What Are Cosmetics According to BPOM?
Cosmetics are products applied to external body parts-skin, hair, nails, lips, and oral cavity-to clean, perfume, protect, or enhance appearance. Common products include:
- Skin moisturizers, creams, oils
- Color cosmetics like lipsticks and foundations
- Hair care products such as shampoos and dyes
- Fragrances and deodorants
- Oral care items like toothpaste and mouthwash
Products with therapeutic claims may be regulated as pharmaceuticals and require separate approval.
Cosmetic Classification by BPOM
BPOM classifies cosmetics based on risk:
- Low-Risk: Basic products like lotions and lip balms
- High-Risk: Products with active ingredients such as sunscreens or skin lightening agents
This classification affects the documentation and scrutiny level during registration.
ASEAN Cosmetic Directive (ACD) Compliance
Indonesia follows the ASEAN Cosmetic Directive, harmonizing regulations across ASEAN countries. This alignment simplifies regional market entry and compliance.
BPOM Product Notification Process
Before marketing, products must be notified via BPOM’s Notifkos system. Key points:
- Local Responsible Party (LRP): Foreign brands must appoint a local entity responsible for notification and compliance.
- Required Documents: Product formula, Certificate of Free Sale, GMP certificate, labels in Bahasa Indonesia, and safety data for high-risk products.
- Notifkos 3.0: Launched in 2025, this system streamlines submissions, allowing easier updates and integration with Indonesia’s Online Single Submission (OSS) system.
Labeling Compliance (BPOM Regulation No. 18/2024)
Labels must be clear, accurate, and in Bahasa Indonesia, including:
- Product name and use
- Full ingredient list (INCI names recommended)
- Directions for use
- Batch number and expiration date
- Manufacturer/importer details
- BPOM notification number and 2D barcode
- Safety warnings
- Halal certification if applicable
English or other languages can be included but must accompany Bahasa Indonesia.
Good Manufacturing Practices (GMP) and Product Information File (PIF)
Manufacturers must comply with ASEAN GMP guidelines. LRPs must maintain a Product Information File containing product summaries, safety data, manufacturing details, and claim substantiation, retained for at least four years.
Post-Market Surveillance (PMS)
BPOM conducts inspections, product testing, advertising reviews, and handles consumer complaints. Non-compliance can lead to recalls, notification cancellations, fines, or legal action.
Halal Certification
Halal certification, though voluntary, is increasingly important in Indonesia. Certified products must display the official Halal logo, regulated by BPJPH and evaluated by LPPOM MUI.
Conclusion
Indonesia’s booming cosmetics market offers great potential, but regulatory compliance is critical. Understanding BPOM’s updated requirements, leveraging Notifkos 3.0, and ensuring proper labeling and documentation will smooth market entry and build consumer trust. Partnering with Maven can help navigate this dynamic landscape efficiently.
Post a comment