BPOM Product License for Cosmetics and Health Goods

Indonesia’s health and beauty market is one of the fastest-growing sectors in Southeast Asia, driven by increasing consumer awareness of product safety, quality, and compliance. However, before any cosmetic or health product can be legally distributed in Indonesia, it must first obtain approval from the National Agency of Drug and Food Control (BPOM).

A BPOM product license serves as proof that a product has passed safety assessments, complies with local regulations, and is safe for public consumption or use. This article provides an in-depth guide on which products require BPOM approval, the application process, and the benefits of having a BPOM license.

Products That Require BPOM Approval

Not every product falls under BPOM’s jurisdiction, but most consumables and topical applications that affect health and safety do. The categories include:

1. Cosmetic Products

• Skin care: lotions, creams, serums, masks.
• Makeup: foundation, lipstick, mascara.
• Personal care: shampoo, soap, deodorant, toothpaste.
  Cosmetics must be registered to ensure they do not contain harmful chemicals or prohibited substances.

2. Health Supplements and Traditional Medicine

• Herbal remedies, jamu, and supplements.
• Vitamins and dietary supplements.
  BPOM ensures these products are free from dangerous additives and meet dosage standards.

3. Medical Devices and Health Goods

• Basic medical tools (e.g., thermometers, masks, test kits).
• Over-the-counter health products that directly affect human health.

4. Food and Beverages (Processed)

• Packaged snacks, drinks, nutritional products.
• Both locally produced and imported goods must pass BPOM checks.

5. Imported Products

• All imported cosmetics, supplements, or processed food must have BPOM registration before entering Indonesian markets.
• Importers need to submit additional documentation such as Certificate of Free Sale (CFS) from the country of origin.

The Application Process for BPOM Product License

Obtaining a BPOM license is a detailed process requiring accurate documentation and compliance with strict standards. The procedure generally involves the following steps:

1. Company Registration

• Only registered business entities (PT Local, PT PMA, or licensed distributors) can apply.
• The company must already have a Business License (NIB) through the OSS system.

2. Product Classification

• Determine the correct product category: food, cosmetics, supplements, or traditional medicine.
• BPOM provides specific classification guidelines that dictate requirements.

3. Document Preparation

Key documents include:

• Certificate of Analysis (COA) proving product quality.
• Formula composition and manufacturing process details.
• Good Manufacturing Practice (GMP) certification from the producer.
• Label and packaging designs complying with BPOM standards (including Bahasa Indonesia labeling).
• Certificate of Free Sale (CFS) for imported products.

4. Submission through e-BPOM System

• Applications are submitted via the BPOM Online Registration System.
• Documents are uploaded for review and evaluation.

5. Laboratory Testing

• BPOM may conduct laboratory analysis to verify product safety.
• Tests check for heavy metals, microbial contamination, and prohibited ingredients.

6. Approval and Issuance of BPOM Number

• If the product passes, BPOM issues an official license number that must be displayed on packaging.
• The license is valid for a certain period (usually 3–5 years) and must be renewed before expiration.

Estimated Time and Cost

• Processing time: Around 20–30 working days, depending on the product category and completeness of documents.
• Cost: Starts from IDR 10,000,000 for standard applications. Costs may increase if additional testing or document legalization is required.

Benefits of Having a BPOM License

1. Consumer Trust and Credibility

A BPOM registration number is a guarantee that the product has been tested and approved by the government, building consumer confidence.

2. Legal Compliance

Operating without BPOM approval can result in penalties, fines, product recalls, or business closure. A license ensures your operations are legally protected.

3. Market Access

Products without BPOM cannot enter official retail channels, supermarkets, pharmacies, or e-commerce platforms. BPOM approval opens doors to these markets.

4. Brand Reputation

Compliance with BPOM standards strengthens brand image, positioning the company as professional, ethical, and trustworthy.

5. International Recognition

Although specific to Indonesia, BPOM approval often serves as a benchmark when entering other markets in Southeast Asia, where safety and regulatory compliance are valued.

6. Competitive Advantage

With rising health awareness, consumers increasingly choose products with clear legal approval. A BPOM license differentiates your product from unregistered competitors.

Common Challenges in BPOM Registration

• Incomplete Documents: Missing COA, GMP certification, or labeling errors can cause delays.
• Regulatory Updates: BPOM frequently updates its requirements; companies must stay current.
• Time-Consuming Process: Especially for imported products requiring international documentation.
• Cost Considerations: Small businesses may struggle with registration fees and testing costs.

Tips for a Successful BPOM Application

1. Prepare documents early to avoid last-minute issues.
2. Work with a local distributor or consultant familiar with BPOM regulations.
3. Ensure accurate labeling in Bahasa Indonesia, including ingredients, manufacturer, and expiration date.
4. Follow Good Manufacturing Practices (GMP) to meet quality control standards.
5. Monitor BPOM updates regularly to stay compliant with new rules.

Case Example: Cosmetic Product Registration

A foreign skincare company wishing to distribute products in Indonesia must:

• Partner with a local PT PMA as an official distributor.
• Obtain CFS and GMP certifications from the country of origin.
• Submit product formulas and labeling in Bahasa Indonesia.
• Pass laboratory testing for heavy metals and banned substances.
  After approval, the company receives a BPOM number, allowing its products to enter retail chains, online marketplaces, and beauty clinics legally.

Conclusion

In Indonesia’s regulated market, obtaining a BPOM product license is not just a formality — it is essential for protecting consumers, complying with the law, and gaining access to broader markets.

By understanding which products require BPOM approval, the step-by-step application process, and the benefits of compliance, businesses in the cosmetics and health sectors can operate confidently and build long-term trust with their customers.

Investing in a BPOM license means investing in safety, credibility, and the sustainable growth of your brand.