Overview

On 8 December 2025, the Head of the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan – BPOM) issued BPOM Decree No. 627 of 2025 concerning Cosmetic Testing Parameters in Certificates of Analysis (CoA) for the Purpose of Import Certificate (SKI Border) Application, which scheduled to take an effect at 8 January 2026.

This decree establishes standardised technical testing parameters that must be reflected in the Certificate of Analysis (CoA) submitted as part of cosmetic Import Certificate Application requirements. The objective is to strengthen pre-market verification, while ensuring that imported cosmetic products meet BPOM’s safety, quality, and compliance standards, particularly in relation to microbiological contamination, heavy metals, and product suitability.

The issuance of this decree also serves as an implementing measure of BPOM Regulation No. 28 of 2023 on the Supervision of the Importation of Drugs and Food into the Territory of Indonesia, which requires stricter control over imported cosmetic products.

Key Regulatory Requirements

Mandatory SKI Border for Cosmetic Imports

In principle, any cosmetic product imported into Indonesia must obtain a Border Import Certificate (SKI Border) issued by BPOM. One of the mandatory documents for the issuance of an SKI Border is a Certificate of Analysis (CoA).

Requirements for the Certificate of Analysis (CoA)

Under BPOM Decree No. 627/2025, the CoA submitted for SKI Border applications must comply with the following conditions:

1. The CoA must be issued by:

• the manufacturer; or

• an accredited laboratory; or

• another industry whose testing laboratory is formally accredited.

2. If the CoA is not issued by the manufacturer, the testing must be conducted by an accredited laboratory using testing parameters determined by BPOM.

Standardised Cosmetic Testing Parameters

The decree specifies that the required testing parameters include, at a minimum:

• Microbiological contamination parameters; and

• Heavy metal contamination parameters,

which must be applied in accordance with the product type and product category, as detailed in the annex of the decree. For example:

Submission and Validity of the CoA

• Business operators must attach a complete CoA, reflecting all applicable testing parameters, at the time of submitting the SKI Border application, in accordance with the parameter table set out in the decree.

• The CoA for microbiological and heavy metal testing is valid for a maximum of one (1) year from the issuance date of the certificate.

Importation of the Same Product with Different Batches

For the importation of the same cosmetic product with different batch numbers, business operators are required to submit:

• A CoA containing the complete testing parameters as stipulated in the decree; and

• A batch-specific CoA for the batch being imported, which must at least include:

a) the dosage form; and

b) organoleptic characteristics.

Scope Limitation

It is important to note that the fulfilment of CoA requirements for SKI Border issuance does not replace nor exempt the obligation to meet product quality requirements under the Product Information File, contamination testing requirements under BPOM Regulation No. 16 of 2024 remain mandatory for PIF compliance as required by BPOM Regulation No. 17 of 2023 Article 3 paragraph (3)(b).

Impact on Cosmetic Importers

With the issuance of BPOM Decree No. 627/2025, cosmetic importers are required to:

1. Review and align their laboratory testing strategies with BPOM’s standardised parameters;

2. Ensure that CoAs are issued by eligible parties and remain within the validity period;

3. Prepare batch-specific documentation for recurring imports; and

4. Anticipate potential delays in SKI Border issuance if testing parameters are incomplete or non-compliant.

Failure to comply with these requirements may result in delays or rejection of SKI Border applications, directly impacting import timelines and product availability in the Indonesian market.

For more information or assistance, please feel free to contact us at customer@reach24h.com.