Regulation of the Food and Drug Authority of Indonesia Number 8 of 2026 Strengthening Good Manufacturing Practice Certification for Cosmetics and Digitalization of the Cosmetics Industry OSS System

Introduction

On April 29, 2026, the Food and Drug Authority of Indonesia (Badan Pengawas Obat dan Makanan, "BPOM") issued Regulation of the Food and Drug Authority of Indonesia Number 8 of 2026 on Certification of Good Manufacturing Practice for Cosmetics ("BPOM Regulation 8/2026"). BPOM Regulation 8/2026 regulates the certification process for Good Manufacturing Practice for Cosmetics (Cara Pembuatan Kosmetik yang Baik, "CPKB") for the cosmetic industry through an electronically integrated business licensing system to ensure product quality, safety, and benefits.

The Government issued BPOM Regulation 8/2026 to align certification arrangements with legal developments and industry requirements, including following the enactment of Law Number 17 of 2023 on Health and Government Regulation Number 28 of 2024 on Implementing Regulations of Law Number 17 of 2023 on Health. Based on the considerans section, the issuance of BPOM Regulation 8/2026 aims to protect the public from the distribution of cosmetics that do not meet quality standards and pose potential health risks. In addition, BPOM Regulation 8/2026 covers the implementation of quality system standards, facility supervision, digitalization of certification services, and the imposition of administrative sanctions.

Comparison

BPOM Regulation 8/2026 repeals and serves to replace Regulation of the Food and Drug Authority of Indonesia Number 33 of 2021 on Certification of Good Manufacturing Practice for Cosmetics ("BPOM Regulation 33/2021"). The following is a comparison between BPOM Regulation 8/2026 and BPOM Regulation 33/2021:

Key Provisions

Account Registration and Integrated Access Rights

Article 3, Article 4, and Article 5 stipulate that businesses must use the business licensing system through the OSS integrated with the BPOM CPKB certification service. To access this service, businesses must register an account on the BPOM CPKB certification service system to obtain a username and password before applying for certification. The business registers by filling in data on the official website of the CPKB certification service. BPOM verifies these applications online, or offline if the online system experiences disruptions. BPOM grants access rights to Cosmetic Industries that possess valid business licensing.

Obligation to Implement CPKB and Production Contract Limitations

Article 2 requires every Cosmetic Industry engaged in product manufacturing activities to implement the CPKB guidelines. Businesses fulfill this obligation by holding a CPKB Certificate or a Class A or Class B CPKB Aspect Fulfillment Certificate. Article 2 also restricts production contract activities, wherein BPOM prohibits Cosmetic Industries that only hold a CPKB Aspect Fulfillment Certificate from accepting production orders from other parties.

Requirements for Technical Person in Charge and Quality System Documents

Article 7 paragraph (1) and Article 11 paragraph (2), as well as Annex II, Annex VI, and Annex VII, require businesses to have a technical person in charge in accordance with the provisions of laws and regulations. Annex II stipulates that to obtain a CPKB Certificate, the business must implement 12 quality system aspects, which include:

1. Quality Management System;

2. Personnel;

3. Buildings and Facilities;

4. Equipment;

5. Sanitation and Hygiene;

6. Production;

7. Quality Control;

8. Documentation;

9. Internal Audit;

10. Storage;

11. Production and Testing Contracts; and

12. Complaint Handling and Product Recall.

Annex VI stipulates that applicants for the gradual Class A CPKB Aspect Fulfillment Certificate capable of producing all forms and types of cosmetic preparations must implement 10 quality system aspects, excluding internal audit and production contracts. Annex VII stipulates that applicants for the Class B CPKB Aspect Fulfillment Certificate producing certain forms and types of cosmetic preparations using simple technology must implement 2 quality system aspects, namely sanitation and hygiene as well as documentation.

Application and Verification Mechanism

The business submits applications through the OSS system by uploading administrative requirements and quality system implementation documents as set forth in Article 7 through Article 14. BPOM verifies the completeness of these documents within a maximum of 7 (seven) working days. After businesses settle the payment based on the payment order within a period of 7 (seven) days, BPOM schedules a factory facility inspection within a maximum of 20 (twenty) working days. BPOM issues the certification decision within a maximum of 35 (thirty-five) working days using a clock-on/clock-off evaluation time mechanism.

Consequences of Rejection and Reapplication

If BPOM identifies discrepancies during the facility inspection, the business may revise the documents a maximum of 3 (three) times with a deadline for submitting revisions of up to 20 (twenty) working days, as stipulated in Article 8 paragraph (6) and Article 12 paragraph (6). Meanwhile, fees that have been paid are non-refundable if BPOM rejects the application, as stipulated in Article 9 paragraph (5) and Article 13 paragraph (6). The business may still reapply, and BPOM determines the necessity of a facility inspection based on the business actor's compliance history in accordance with Article 10.

Data Amendments Impacting the Business Identification Number

Amendments to CPKB Certificate data that impact the Business Identification Number (Nomor Induk Berusaha, “NIB”) require businesses to apply for the issuance of a new certificate, as stipulated in Article 21. In this case, businesses cannot use the certificate amendment mechanism. BPOM requires businesses to submit an application for a new CPKB Certificate in accordance with the initial application procedures as set forth in Article 7 through Article 10.

Grouping and Compliance of Cosmetic Preparation Forms

BPOM issues certificates based on the form of cosmetic preparations and not for all product types generally, as stipulated in Article 15 and Annex X. Certificates apply to each approved cosmetic preparation form, and the business must manufacture cosmetics in accordance with the preparation forms listed in the certificate. Annex X categorizes cosmetic preparations into five categories, namely solid, powder, semi-solid, liquid, and aerosol. Should a business intend to manufacture preparation forms outside of those listed in the certificate, the business must apply for a new certificate.

Certificate Renewal and Stringent Tightening for Class A

The validity period of the CPKB Certificate and the CPKB Aspect Fulfillment Certificate is 5 (five) years from the date of issuance, as stipulated in Article 16 through Article 19. The business must apply for renewal at the earliest 6 (six) months or at the latest before the validity period of the CPKB Certificate or CPKB Aspect Fulfillment Certificate expires. For the Class A CPKB Aspect Fulfillment Certificate, businesses may only apply for gradual renewal a maximum of 1 (one) time, as stipulated in Article 18 paragraph (5). BPOM processes certificate renewals with or without facility inspections based on the evaluation results and risk levels.

Certificate Revocation Upon Request

Businesses have the right to voluntarily submit a request for the revocation of a CPKB Certificate or CPKB Aspect Fulfillment Certificate to the Head of BPOM. This revocation request from the company must be submitted by including adequate justification documents regarding the reasons for revocation, as stipulated in Article 17.

Delays in Certificate Renewal Applications

If a business submits a renewal application after the certificate validity period expires, the business cannot renew the certificate, as stipulated in Article 24 and Article 28. Under such conditions, BPOM treats the facility as a new application and requires the business to apply for a new certificate through all application stages.

Administrative Amendments

The business may apply for administrative amendments, which include among others changes to the business entity name, changes to the board of directors or technical person in charge, and changes of address provided they are not accompanied by a relocation of the facility, as stipulated in Article 20 through Article 29. BPOM processes administrative amendments within a maximum of 10 (ten) working days without a facility inspection, and the previous certificate is declared invalid.

Technical Amendments

Technical amendments include, among others, the addition or expansion of rooms that affect capacity and cleanliness levels. BPOM processes the evaluation of technical amendments within a maximum of 35 (thirty-five) working days and may conduct a facility inspection. In the event that technical amendments are approved, the previous certificate remains valid as an addendum, as stipulated in Article 25 paragraph (3).

Use of Shared Production Facilities and Fee Waivers

Businesses may use cosmetic production facilities to manufacture Quasi-Drugs and/or Household Health Supplies after obtaining approval from the Head of the Agency through the OSS system, as stipulated in Article 30 through Article 41. Such applications must be accompanied by cross-contamination risk control documents, including machine capacity data, cleaning procedures, raw material specifications, and production segregation schedules. The issuance of the CPKB Aspect Fulfillment Certificate and the approval for the use of shared production facilities for Quasi-Drugs are exempted from Non-Tax State Revenue (Penerimaan Negara Bukan Pajak, “PNBP”) fees, as stipulated in Article 45.

Transitional Provisions

CPKB Certificates, Statements of CPKB Implementation, Certificates of CPKB Aspect Fulfillment, and approvals for the use of shared production facilities that were issued prior to the enactment of BPOM Regulation 8/2026 remain valid until their validity periods expire, as stipulated in Article 44. Businesses may use these documents as long as they are still valid.

BPOM may impose administrative sanctions on Cosmetic Industries that do not comply with CPKB implementation provisions, manufacture preparation forms outside of those approved, or use certificates that have expired. The types of sanctions include written warnings, restriction of service access, temporary suspension of production activities, suspension of certificates, and revocation of certificates, as stipulated in Article 42.

Closing

BPOM Regulation 8/2026 establishes a Good Manufacturing Practice certification system for cosmetics integrated through the OSS with BPOM, covering account registration, document verification, and technical evaluation, up to certificate issuance, while eliminating the Approval of Building Floor Plan stage and shifting the assessment to quality system fulfillment and a risk-based approach. This regulation emphasizes the obligation to implement CPKB as the basis for cosmetic production activities, accompanied by restrictions on production contracts for businesses that do not yet possess full certification, as well as the determination of certificates that are specific to preparation forms, ensuring that any product development outside the certificate's scope requires a new application. The certification validity period is set for five years with a more structured renewal mechanism, including restrictions on gradual renewals for holders of the Class A CPKB Aspect Fulfillment Certificate, and affirms that renewal delays require a completely new application. From a procedural standpoint, all application, verification, and evaluation stages are governed by clear deadlines through a clock-on/clock-off scheme encompassing document inspection, payment, facility inspection, and the issuance of certification decisions. This is accompanied by repair and re-evaluation mechanisms if discrepancies are found, as well as certificate amendment regulations distinguishing between administrative and technical amendments with differing consequences, including the issuance of new certificates under certain conditions. In the event of non-compliance, BPOM may impose tiered administrative sanctions ranging from written warnings to certificate revocation, including service restrictions and the temporary suspension of production activities. On the other hand, incentives are provided in the form of waivers for Non-Tax State Revenue fees for the CPKB Aspect Fulfillment Certificate and the approval of shared production facilities for Quasi-Drugs and Household Health Supplies, while maintaining the validity of previously issued certificates until their expiration.