In the Indonesian regulatory landscape, the cosmetic product notification process is governed by the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan or BPOM), which enforces stringent standards to ensure product safety, efficacy, and quality before products are legally marketed. As part of this regulatory process, companies intending to sell cosmetic products in Indonesia are required to first obtain the RSPN (Rekomendasi sebagai Pemohon Notifikasi) from the local BPOM office. This recommendation affirms the eligibility of the applicant—typically a company domiciled in Indonesia—to act as a notifier for cosmetic products.

The issuance of an RSPN confirms that the applicant has fulfilled the necessary requirements regarding legal entity status, operational readiness, and manufacturing or distribution capabilities. However, securing the RSPN is only the initial step in a broader compliance pathway. Once the RSPN is obtained, the company must submit a complete product notification application through BPOM’s online e-Notifikasi system to the central BPOM office in Jakarta.

Despite the successful acquisition of the RSPN, it is not uncommon for applicants to receive technical or administrative notes (catatan) from BPOM Central during the dossier evaluation phase. These remarks typically pertain to discrepancies in labeling, unsupported claims, non-compliance with ingredient limitations, incomplete documentation, or formulation-related concerns. Failure to address these notes adequately and within the stipulated response period may result in significant delays—or even outright rejection—of the application, necessitating costly resubmissions or reformulations.

This article provides a detailed overview of how to effectively respond to such “catatan”, with a focus on the implementation of Corrective Action and Preventive Action (CAPA) as a structured methodology for resolving deficiencies and preventing recurrence. It also underscores the critical role that a qualified regulatory consultant—such as ET Consultant—can play in facilitating a smooth, efficient, and compliant product notification process from initial RSPN acquisition to final notification issuance.

To ensure that only safe and compliant cosmetic products enter the Indonesian market, BPOM has established a structured multi-phase notification process. This process involves both administrative and technical validations and comprises the following essential stages:

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1. RSPN Issuance by Local BPOM (Rekomendasi sebagai Pemohon Notifikasi)

Before any cosmetic product can be submitted for notification, the applicant must first obtain an RSPN from the local BPOM office (based on the company’s domicile). This document serves as a formal recommendation stating that the company is eligible to act as a “Pemohon Notifikasi” or notifier under Indonesian law. To obtain the RSPN, the applicant must fulfill several key requirements, including but not limited to:

• • Possessing a valid business license under the appropriate KBLI code
  • Having access to proper manufacturing or distribution facilities
  • Demonstrating sufficient understanding of Good Manufacturing Practices (GMP) or adequate product handling capacity
  • Ensuring personnel qualifications (e.g., a responsible pharmacist or qualified technical personnel)

The RSPN acts as a gatekeeping mechanism to ensure that only credible and compliant entities can initiate cosmetic notification applications at the central BPOM level.

2. Notification Submission to BPOM Central (Registration POM)

Following the issuance of the RSPN, the applicant may proceed to submit a formal notification dossier to BPOM Central in Jakarta through the BPOM system, which is BPOM’s dedicated online platform for cosmetic registration. A complete notification dossier generally includes:

• • Product information (name, function, category)
  • Formatted ingredient list and concentration breakdown
  • Safety documentation, such as Material Safety Data Sheets (MSDS) and Certificates of Analysis (COA)
  • Certificate of Free Sale (CFS) or equivalent for imported products
  • Packaging and labeling design drafts (including claims and usage instructions)
  • Justification of any functional claims made
  • Photographic samples of the actual product (when required)

The submission is evaluated not only for completeness but also for compliance with existing cosmetic safety regulations, banned ingredient lists, permissible limits, labeling standards, and claim substantiation requirements.

3. BPOM Central Evaluation and Decision Process

Once the dossier is submitted, BPOM Central conducts a thorough administrative and technical evaluation. This includes cross-checking ingredient safety, verifying claim validity, reviewing the alignment between labeling and product formulation, and ensuring that all required documentation is properly submitted. During this stage, BPOM may issue remarks or notes (catatan) that the applicant must address. These notes could pertain to:

• • Technical inconsistencies or non-compliant formulations
  • Ambiguous or exaggerated product claims
  • Inadequate documentation or missing certificates
  • Non-conformity of label content (font size, warning phrases, translation accuracy)
  • Incorrect product classificationApplicants are typically granted a fixed period—usually 14 to 30 working days—to address the remarks and re-upload revised documents or provide clarifications.

If the applicant successfully addresses all of BPOM’s concerns within the stipulated time, a Notification Number (Nomor Notifikasi) will be issued, signifying that the product is now legally authorized for distribution in the Indonesian market.This multi-layered process underscores the importance of accuracy, regulatory literacy, and proactive compliance. Failure to comply with any stage may result in significant delays, rejections, or reputational harm, especially for foreign brands unfamiliar with the Indonesian regulatory environment.

To minimize these risks, many companies rely on experienced regulatory consultants like ET Consultant, who can guide clients through each stage—from RSPN acquisition and dossier preparation to handling BPOM notes and securing the final notification approval.

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Common Issues Leading to BPOM Notes

Despite having obtained the RSPN and having submitted the cosmetic product notification dossier, it is not uncommon for applicants to receive technical or administrative notes (catatan) from BPOM Central. These notes typically arise during the evaluation process and may highlight issues that must be resolved before the Nomor Notifikasi can be granted. The most frequently encountered issues include:

1. Discrepancies in Composition or Formulation Details
   Variations between the declared ingredients and those listed in supporting documents (e.g., MSDS, COA) may raise red flags, especially if concentration levels exceed permissible limits or if the product includes restricted substances.
   
2. Unjustified or Misleading Product Claims
   Claims such as “whitening,” “anti-aging,” or “dermatologically tested” must be substantiated with relevant scientific data or safety assessments. Failure to provide proper justification may render the claims misleading and result in note issuance.
   
3. Labeling Non-Compliance with BPOM Standards
   Common labeling errors include missing mandatory information (e.g., production code, net content, warnings), non-compliance with font size or language requirements, and inaccurate translation from foreign languages.
   
4. Incomplete Safety Documentation
   Absence of critical documentation such as Material Safety Data Sheets (MSDS), Certificates of Analysis (COA), or Certificates of Free Sale (CFS) may result in BPOM withholding approval pending clarification or resubmission.
   
5. Product Classification Errors
   Misclassifying a product (e.g., submitting a borderline cosmetic as a conventional cosmetic) can lead to immediate rejection or a request for reclassification under a more stringent regulatory regime.
   

These issues are not only procedural but also reflect deeper concerns regarding consumer safety, product transparency, and regulatory integrity. As such, applicants are strongly advised to approach the notification process with diligence and foresight.

Corrective and Preventive Actions (CAPA): Strategic Response

In the event that BPOM Central issues notes or remarks, the most effective way to respond is through a structured Corrective Action and Preventive Action (CAPA) framework. This dual-pronged strategy enables businesses to remedy immediate deficiencies while also strengthening compliance controls to avoid similar issues in future submissions.

Corrective Action: Immediate Resolution

Corrective action refers to the direct response to the specific deficiencies identified by BPOM. Key steps include:

1. Detailed Review of BPOM Notes
   Carefully assess each note issued to determine whether the issue lies in documentation, labeling, formulation, or product claims. Engaging a regulatory expert at this stage can help interpret the regulatory rationale behind each note.
   
2. Document Revision and Resubmission
   Amend the affected sections of the dossier, whether it involves correcting ingredient concentrations, revising claims, or reformatting labels to meet BPOM’s visual and textual standards.
   
3. Submission of Supporting Evidence
   Provide technical justifications, such as scientific literature, clinical studies, or third-party lab analyses, to support the safety, efficacy, and legitimacy of the product’s features and contents.
   
4. Timely Compliance with Response Deadlines
   It is critical to submit corrections within the prescribed timeframe, typically 14 to 30 business days. Failure to comply may result in the termination of the notification process and the requirement to start over, incurring additional time and cost.
   

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Preventive Action: Long-Term Compliance

Preventive action focuses on ensuring that future submissions are free of similar deficiencies. Best practices include:

1. Pre-Submission Internal Audit
   Conduct a thorough review of the dossier and supporting materials prior to submission. This includes cross-checking all documents for consistency, validating claims, and reviewing label designs against BPOM standards.
   
2. Technical and Regulatory Benchmarking
   Ensure that all product data, including formulation and safety documentation, aligns with the most current BPOM regulations and international best practices.
   
3. Engagement of Qualified Regulatory Consultants
   Partnering with an experienced regulatory consultant, such as ET Consultant, ensures that your documentation is technically robust and regulatorily sound. Consultants also provide strategic advice to position your product favorably within the regulatory landscape, minimizing rejections and delays.

The Consequences of Non-Compliance

Failure to address BPOM’s remarks within the allotted timeframe may result in:

1. Formal rejection of the notification application
2. Loss of all submission progress and administrative fees
3. Re-initiation of the entire notification process
4. Potential reputational damage, especially for foreign principals and local importers managing multiple SKUs

Hence, the adoption of a strong CAPA framework, combined with expert guidance, is not only a corrective tool but also a strategic safeguard for business continuity and market access in Indonesia.

Conclusion

Navigating the cosmetic product notification process in Indonesia requires more than just regulatory awareness—it demands strategic execution, technical precision, and proactive compliance planning. While obtaining the RSPN marks a critical starting point, the path to securing the official Nomor Notifikasi is often fraught with technical reviews, regulatory scrutiny, and potential setbacks in the form of BPOM’s catatan (notes).

By adopting a structured Corrective Action and Preventive Action (CAPA) framework, businesses can not only address immediate deficiencies but also build sustainable compliance mechanisms that reduce the likelihood of future rejections. The ability to respond promptly, submit accurate documentation, and understand the regulatory context of each BPOM remark is vital to maintaining momentum in the approval process.

However, given the complexity of the regulatory environment and the evolving nature of BPOM’s standards, businesses—especially foreign manufacturers and local importers—are strongly encouraged to engage a qualified regulatory consultant.

As a trusted compliance partner, ET Consultant provides end-to-end assistance from RSPN acquisition and dossier preparation to resolving BPOM notes and securing final product notifications. Our deep understanding of Indonesian cosmetic regulations, combined with a proven track record in managing complex submissions, allows us to deliver timely, accurate, and compliant outcomes for our clients.

In an increasingly regulated and competitive market, ensuring that your cosmetic products meet all statutory requirements is not just a matter of legality—it is a business imperative. Let ET Consultant help you navigate this journey with confidence, efficiency, and regulatory assurance.

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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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