Indonesia BPOM, Draft Announcement of the Amendment to the Regulation on the Service Standards of OTSKK (Evaluation of Cosmetic Safety, Quality, and Efficacy)
In order to distribute cosmetics in Indonesia, products must be registered or notified with the Indonesian National Agency of Drug and Food Control (BPOM). For certain products that contain new ingredients or are classified as new products, an evaluation by the Directorate of Standardization of Traditional Medicines, Health Supplements, and Cosmetics (OTSKK) is required.
On April 9, 2025, the Directorate of Standardization of Traditional Medicines, Health Supplements, and Cosmetics (OTSKK) of Indonesia announced a draft regulation issued by the National Agency of Drug and Food Control (BPOM), outlining the service standards for the evaluation of the safety, quality, and efficacy of traditional medicines, health supplements, and cosmetics.
The key provisions of the regulation are as follows:
1) General requirements
- The service application must be submitted directly by the business entity intending to conduct the registration or notification
- The use of intermediaries or agents in submitting the application is not permitted
- An application letter requesting the evaluation of traditional medicines, quasi-drugs, health supplements and cosmetics must be attached.
2) Specific requirements
2.1) For cosmetic ingredients, supporting data must include the following:
a. Safety of plant-based cosmetic ingredients
① The procedures and requirements must follow the Guidelines for the Safety Assessment of Plant-Based Raw Materials for Cosmetics (Pedoman Penilaian Keamanan Bahan Baku Tumbuhan untuk Kosmetika).
② Plant-based ingredients used as colorants, preservatives, or UV filters in cosmetics manufactured in Indonesia can only be submitted if they are derived from plants native to Indonesia. The procedures and requirements must follow the Guidelines for the Safety Assessment of Plant-Based Raw Materials for Cosmetics (Pedoman Penilaian Keamanan Bahan Baku Tumbuhan untuk Kosmetika), and efficacy data must also be submitted using valid and up-to-date methodologies.
③ Results of an independent (self-conducted) safety evaluation of the ingredient
b. Safety of non-plant based cosmetic ingredients
① Physicochemical characteristics
② Function of the cosmetic ingredient
③ Quantitative concentration (%) of the ingredient used in the final product
④ Method of use (rinse-off or leave-on product)
⑤ Route of exposure (e.g., oral, dermal, inhalation)
⑥ Toxicity data according to conditions of use
⑦ Exposure information related to the ingredient
⑧ Regulatory status and usage data from other countries (if available)
⑨ Adverse event reports related to cosmetics containing the ingredient in circulation (if required)
⑩ Other safety support data based on published references or scientific journals
⑪ For cosmetic ingredients in the form of nanomaterials, the following additional data must be submitted:
- Absorption data of the ingredient (including particle size)
- Supporting data on product safety, efficacy, and/or quality
⑫ Natural ingredients (excluding plants) used as colorants, preservatives, or UV filters in cosmetics manufactured in Indonesia may only be submitted if they are sourced from Indonesia. In addition to safety and quality documentation, efficacy data must also be provided using valid and up-to-date methodologies.
⑬ Results of an independent (self-conducted) safety evaluation of the ingredient
It also includes evaluation documents for Class B cosmetic industries (small business) and for cosmetics sold cosmetic refill facilities.
Please refer to the attached document below.
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