The BPOM Regulation No.16 of 2024 in Indonesia updates the contamination limits for cosmetics. It replaces the BPOM Regulation No. 12 of 2019. The allowed limits of contamination, including microbial, heavy metals, and chemicals, are now stricter.
This means, for cosmetic manufacturers, importers, and brands entering the Indonesian market, it is important to ensure they meet this compliance. Read this blog to understand everything about the updated contamination limits and how to avoid delays and rejections.
What has changed with the BPOM Regulation No. 16 of 2024?
The new regulation updates the contamination levels and intensifies testing on cosmetics sold in Indonesia.
Key updates include:
- New heavy metal, microbial, and chemical impurity limits
- New regulation of the 1,4-dioxane standard, from 25 ppm to 10 ppm.
- Contamination can be divided into three groups: micro, heavy metal, and chemical.
- Required testing, through validated analytical methods
- Testing needs for accredited and GMP-compliant laboratories
- New cosmetic compliance for cosmetic manufacturers and importers in Indonesia
Types of Contaminants identified by BPOM (NADFC)
According to the NADFC BPOM regulation number 16/2024, the types of contaminants are classified into 3, they are microbial, heavy metal and chemical contaminants.
- Microbial contaminants: They are the contaminants that are found in cosmetics which originate from microbes that can be the cause of harm to human health.
- Heavy metal contaminants: These are cosmetic contaminants which are in the form of metallic chemical elements and metalloids. They have high atomic weight and density. Apart from this they are also toxic and have the potential to harm the health.
- Chemical contaminants: These contaminants in cosmetics originate from chemical elements or compounds that can harm human health.
It is not that the cosmetic products must be completely devoid of these substances but there are certain limits (range) to which it can be present in the cosmetic products.
Learn how our cosmetics regulatory affairs services in Indonesia simplify BPOM compliance.
Maximum Permitted Limits Under BPOM Cosmetic Contamination Limits
According to BPOM Regulation No. 16 of 2024, the limits of the presence of heavy metals, microbial, and chemical contaminants in cosmetic products that can be distributed in Indonesia are stipulated.
Heavy Metal Limits
BPOM has established regulations for the presence of heavy metals in cosmetics to reduce the risk of toxicity from these substances due to raw materials or cosmetics production.
| Heavy Metal | Maximum Limit |
| Lead (Pb) | ≤ 20 ppm |
| Mercury (Hg) | ≤ 1 ppm |
| Arsenic (As) | ≤ 5 ppm |
| Cadmium (Cd) | ≤ 5 ppm |
Microbial Limits
BPOM also sets out microbiological specifications for cosmetics, which are required to limit contamination in production, storage, and in use by consumers.
| Testing Parameter | Category A Cosmetics | Other Cosmetics |
| Total Plate Count | ≤ 500 CFU/g or CFU/ml | ≤ 1,000 CFU/g or CFU/ml |
| Yeast & Mold Count | ≤ 500 CFU/g or CFU/ml | ≤ 1,000 CFU/g or CFU/ml |
| Pseudomonas aeruginosa | Negative in 0.1 g or 0.1 ml | Negative in 0.1 g or 0.1 ml |
| Candida albicans | Negative in 0.1 g or 0.1 ml | Negative in 0.1 g or 0.1 ml |
| Staphylococcus aureus | Negative in 0.1 g or 0.1 ml | Negative in 0.1 g or 0.1 ml |
The following products are in Category A:
- children’s products under 3 years of age,
- products used around the eyes,
- and for use on mucous membranes.
Chemical Contaminant Limits
BPOM also sets the limits for some chemical contaminants that can be accidentally found in cosmetics.
| Chemical Contaminant | Maximum Limit |
| 1,4-Dioxane | ≤ 10 mg/kg or 10 mg/L |
| Acrylamide | ≤ 0.1 mg/kg for non-rinse body care products; ≤ 0.5 mg/kg for other products |
| Diethylene Glycol | ≤ 0.1% |
Testing and Laboratory Requirements Under BPOM
According to the BPOM Regulation No. 16 of 2024, contamination testing of cosmetic products must be carried out by analytical methods that have been validated or verified.
Testing can be done at the following locations:
- Accredited external laboratories,
- Internal laboratories of cosmetic manufacturers who have been issued a cosmetic GMP certificate or cosmetic compliance certification.
To assist BPOM compliance, companies distributing cosmetics in Indonesia should maintain the proper documentation of the laboratory, analytical methods, and quality control in their records.
Penalties for Non-Compliance With BPOM Cosmetic Regulations
Companies that do not meet the requirements of BPOM contamination can be sanctioned by the Administration in the following ways:
- written warnings,
- Suspension of Cosmetic Distribution for a period of time,
- Product recalls or destruction, or
- short-term temporary suspension of the production or import of cosmetics,
- Revocation of Cosmetic Notification approvals, and
- and a temporary ban on access to the Notification submission system online by BPOM.
How Cosmetic Companies Can Prepare for BPOM Regulation No. 16 of 2024
Manufacturers and importers of cosmetics in Indonesia need to re-evaluate the quality and compliance systems for their products in order to comply with BPOM Regulation No. 16 of 2024.
Step 1: Check Contamination Testing Specifications.
Discuss the testing specifications of finished and raw products, with a focus on compliance with BPOM’s updated contamination limits on chemicals, microbial, and heavy metal contaminants.
Step 2: Re-Evaluate Supplier Qualification Procedures:
Determine and assess supplier qualification procedures and quality agreements to ensure the raw materials and ingredients comply with the new BPOM contamination requirements.
Step 3: Laboratory Test Methods Validation.
Ensure microbial and chemical contaminant testing methods are validated/verified according to the BPOM laboratory requirements.
Step 4: Maintain Up-To-Date Product Documentation.
Revise Product Information Files (PIFs), contamination test reports, and supporting quality documentation to comply with the changed regulatory requirements.
Step 5: Perform a Compliance Gap Assessment
Conduct an internal gap assessment to find products, formulations, or manufacturing processes that may need correction before they are distributed to Indonesia.
Step 6: Ensure That Third Party Manufacturing Compliance Is Reviewed
The companies using imported cosmetics or contract manufacturers should make sure that third-party facilities and testing laboratories meet BPOM’s new contamination and quality standards.
Conclusion
The market access in Indonesia can be delayed, and product recall and notification suspension will occur due to the failure to meet the BPOM contamination requirements.
Artixio offers cosmetic manufacturers and importers, along with regulatory teams, BPOM compliance, contamination testing strategy, cosmetic notification support, and regulatory market entry solutions, not only for the local market (Indonesia) but also in the global market. Contact Artixio today at info@artixio.com.
