5 Types of Testing Required Before a Cosmetic Product Can Be Registered with BPOM
Before a cosmetic product can be legally marketed in Indonesia, manufacturers must obtain marketing authorization from the Indonesian Food and Drug Authority (BPOM). The legal framework is established through several regulations, beginning with Minister of Health Regulation No. 1176/MENKES/PER/VIII/2010 on Cosmetic Notification, and more recently BPOM Regulation No. 25 of 2025 on the Technical Requirements for Cosmetic Ingredients, which came into effect on October 3, 2025, replacing BPOM Regulation No. 23 of 2019 and its amendments.
This regulation explicitly states that the technical requirements for cosmetic ingredients are based on three fundamental aspects: safety, efficacy, and quality. These three pillars are demonstrated through various laboratory tests before a cosmetic product can be submitted for notification.
Without valid test results generated using recognized analytical methods, a cosmetic notification or marketing authorization application may be delayed or rejected. For cosmetic manufacturers, understanding the required laboratory tests from the beginning can significantly streamline the registration process while minimizing the need for repeated revisions.
This article discusses the major laboratory tests that should be prepared before submitting a cosmetic product to BPOM, based on the applicable regulations.
Table of Content:
- Microbiological Testing Cosmetic Product
- Physicochemical Testing
- Safety Testing: Irritation and Sensitization
- Active Ingredient Assay
- Heavy Metal Contaminant Testing
Microbiological Testing Cosmetic Product
Microbiological testing is one of the mandatory requirements during the cosmetic registration process because products contaminated with microorganisms may pose serious risks to consumer health. The analytical methods are officially specified in BPOM Head Regulation HK.03.1.23.08.11.07331 of 2011 on Cosmetic Analysis Methods, which describes procedures for determining total yeast and mold counts as well as preservative efficacy testing through sample incubation on selective media followed by microbial colony enumeration.
The objective of this testing is to ensure that cosmetic products remain free from bacteria, molds, or yeasts exceeding the acceptable limits throughout storage and consumer use. In addition to determining the total microbial count, laboratories also test for the presence of specific pathogenic microorganisms that are prohibited in cosmetic products according to the regulation.
Satisfactory microbiological test results indicate that both the formulation and manufacturing process comply with the hygiene standards established by the regulatory authority.
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Physicochemical Testing
In addition to microbiological quality, cosmetic products must undergo physicochemical testing, which evaluates physical and chemical characteristics such as pH, viscosity, color stability, and formulation homogeneity. These tests ensure that the product remains stable throughout its shelf life and does not undergo significant changes that could affect its quality or consumer acceptance.
For example, the pH must be appropriate for the intended product type and application site to minimize the risk of skin or eye irritation. Stability testing is typically performed under various storage conditions to simulate the effects of temperature and humidity during transportation and consumer storage.
Comprehensive and consistent physicochemical data enhance the credibility of the product during BPOM's evaluation process.
Safety Testing: Irritation and Sensitization
Safety is one of the three core pillars established under BPOM Regulation No. 25 of 2025 on the Technical Requirements for Cosmetic Ingredients. Consequently, demonstrating product safety through irritation and sensitization testing is not merely recommended but forms part of the technical requirements that manufacturers must fulfill.
Irritation testing is conducted to determine whether a cosmetic product has the potential to cause adverse reactions to the skin or eyes following direct contact. Through toxicological evaluation, manufacturers can identify ingredients that may cause redness, itching, or burning sensations.
Sensitization testing is equally important because it assesses the possibility of allergic reactions resulting from repeated product use over time. Together, these studies provide scientific evidence that supports formulation optimization before commercialization.
Strong safety data also help manufacturers build consumer confidence and strengthen their brand reputation as providers of safe cosmetic products.
Active Ingredient Assay
The remaining two pillars of BPOM Regulation No. 25 of 2025, require that every active ingredient used in cosmetic formulations falls within specified concentration limits to ensure both product safety and intended performance. Active ingredient assay is performed to verify that the concentration does not exceed regulatory limits while remaining sufficient to deliver the claimed benefits.
This analysis also confirms that the active ingredient content stated on the product label accurately reflects the actual formulation, protecting consumers from misleading claims. Any discrepancy between the labeled claim and laboratory findings may become grounds for rejection during the BPOM notification process.
Therefore, manufacturers should ensure that laboratory assay results are fully consistent with both the product formulation and marketing claims.
Heavy Metal Contaminant Testing
Heavy metals such as mercury (Hg), lead (Pb), arsenic (As), and cadmium (Cd) are among the most strictly regulated contaminants in cosmetic products. These substances may unintentionally enter cosmetic formulations through contaminated raw materials, manufacturing processes, or packaging materials.
Heavy metal testing is conducted to ensure that these hazardous contaminants remain well below the maximum permissible limits or are not detectable at all. Oversight of raw material contaminants has been further strengthened through BPOM Regulation No. 26 of 2025 on Risk Assessment for the Use of Raw Materials, which was introduced following poisoning incidents associated with ethylene glycol (EG) and diethylene glycol (DEG) contamination.
The regulation emphasizes the importance of objective and transparent risk assessments for cosmetic raw materials. Failure to adequately control these contaminants may result in product recalls, even after marketing authorization has been granted.
Conclusion
Overall, laboratory testing forms the foundation of the BPOM cosmetic registration process. From microbiological and physicochemical testing to safety assessments, active ingredient assays, and heavy metal analysis, each evaluation plays a critical role in demonstrating that a cosmetic product is safe, stable, and consistent with its claimed benefits.
Collaborating with an experienced and accredited testing laboratory can help manufacturers accelerate the notification process while strengthening consumer trust in their products. By preparing comprehensive laboratory data from the outset, companies can significantly reduce the risk of application delays or regulatory rejection.
Complete Your Cosmetic Testing Data with IML Testing and Research
Do not let incomplete testing data delay your cosmetic product registration. Conduct quality, safety, stability, microbiological, and other relevant tests with IML Testing & Research to support your product documentation before submission to BPOM.
Author: Jihan
Editor: Lina
REFERENCES
Badan POM (BPOM). 2011. Peraturan Kepala Badan Pengawas Obat dan Makanan Republik Indonesia Nomor HK.02.1.23.08.11.07331 Tentang Metode Analisis Kosmetika
Badan POM (BPOM). 2025. Peraturan BPOM Nomor 25 Tahun 2025 tentang Persyaratan Teknis Bahan Kosmetik.
Kementerian Kesehatan Republik Indonesia. (2010). Peraturan Menteri Kesehatan Republik Indonesia Nomor 1176/MENKES/PER/VIII/2010 tentang Notifikasi Kosmetika. Kementerian Kesehatan Republik Indonesia.
