Indonesia Reveals Non-Compliant Products Identified During Supervision and Inspection

1. 16 Cosmetic Products Non-Compliant for Needle or Microneedle Application

From September 2023 to October 2024, BPOM conducted an intensive supervision of cosmetics circulation. As a result of this oversight, the Directorate of Standardization of Traditional Medicines, Health Supplements, and Cosmetics issued an announcement on November 21, 2024, revealing that 16 cosmetic products were being used or applied like medicines through needles or microneedles. ¹ The wide circulation and use of products notified as cosmetics but applied via needles has been successfully identified by BPOM, which needs regulation.

These non-compliant products exhibit clear characteristics: they possess a notification number as cosmetics and are typically packaged in liquid form—such as ampoules, vials, or bottles—either accompanied by or without a syringe. However, their labeling and promotional materials indicate that they are intended for injection.

It is crucial to note that injectable products must be sterile and administered by qualified medical personnel. In contrast, cosmetics, which are not sterile, are designed for general consumer use without medical assistance and not intended to affect layers of skin below the epidermis. Therefore, despite being notified as cosmetics, these products violate regulations and pose health risks to users.

Inappropriate use of these products via injection—especially by non-medical personnel—can lead to serious health issues, including allergic reactions, infections, skin damage, and systemic side effects. Dr. Ikrar emphasized, “Using cosmetics by injection is very dangerous. Products used through injection are classified as drugs and must be registered as medicinal products.”

Measures Taken

In response to these violations, BPOM has imposed administrative sanctions, including the revocation of notification numbers and orders for the product owners to recall and destroy the non-compliant products. In addition, BPOM strongly urges businesses to operate in accordance with applicable laws and regulations, ensuring that products are correctly registered or notified in their respective categories.

BPOM also calls on medical personnel to be vigilant about the categories of products they apply to patients, and urges the public to purchase and use only those cosmetic products with valid notification numbers, avoiding those intended for injection.

Comments

According to BPOM Regulation No.21 of 2022, cosmetic products are defined as materials or preparations intended for use on the external parts of the human body, such as the epidermis, hair, nails, lips, external genital organs, and oral mucous membranes. Their purposes include cleaning, perfuming, altering appearance, improving body odor, and/or maintaining good condition. Thus, products used with needles or microneedles, or administered via injection, do not fall under the cosmetic category.

Cosmetic notifiers must ensure that the application sites, methods, and efficacy of the product align with the definition of cosmetics. Failure to do so risks the revocation of their notification number and subsequent recall and destruction of the product.

2. 55 Cosmetic Products Non-Compliant Due to Prohibited or Hazardous Ingredients

On December 3, 2024, BPOM announced 55 cosmetic items containing prohibited or hazardous ingredients during inspections conducted from November 2023 to October 2024. ² The findings included 35 products made under production contracts, 6 products produced and distributed by Indonesian cosmetic manufacturers, and 14 imported items.

Prohibited/Hazardous Ingredients Detected

Commonly found prohibited or hazardous ingredients in these 55 cosmetic items include:

• Mercury: Can cause skin discoloration, allergies, irritation, headaches, diarrhea, vomiting, and kidney damage;

• Lead: Can damage organ function and body systems;

• Retinoic Acid: May lead to dry skin, burning sensations, and potential fetal harm (teratogenic effects);

• Hydroquinone: Can cause hyperpigmentation, ochronosis (darkening of the skin), and changes in cornea and nail color;

• Red K3, Red K10, and Acid Orange 7 Dyes: Carry carcinogenic risks and may impair liver function.

Measures Taken

For products confirmed to contain prohibited and/or hazardous ingredients, BPOM has revoked their notification numbers and temporarily suspended all related activities, including production, distribution, and imports. Businesses involved are required to recall the products for destruction and report the recall results to BPOM. Additionally, BPOM has conducted control measures through 76 technical implementation units across Indonesia, focusing on production facilities, distribution, and online platform.

BPOM also investigates the production, distribution, and promotion of non-compliant cosmetics, particularly those produced by unauthorized parties. If criminal indications are found, a pro-justitia process will be initiated by BPOM's Civil Servant Investigators.

In addition, this supervision has led to the discovery of numerous illegal cosmetic links. During the inspection period, 53,688 such links were reported to the Ministry of Communication and Digital and the Indonesian E-commerce Association (idEA) for takedown.

Comments

Over the past five years, the Indonesian domestic cosmetics industry has shown significant positive growth. By the end of October 2024, the number of cosmetics enterprises in Indonesia reached 1,249, marking a 16.40% increase from the previous year. The total number of cosmetic products with BPOM notifications stood at 283,391, among which 68.80% were Indonesian local products.

Despite this growth, BPOM has noted an increase in violations within the cosmetics sector. Therefore, BPOM will continue to monitor the circulation of cosmetics to ensure compliance with health standards while supporting the development of Indonesian domestic cosmetic enterprises. It is also intensifying supervision of imported cosmetics to protect public health.