Indonesia Proposes Revisions to Cosmetic Safety, Quality, and Efficacy Assessment Application Dossiers

Background

To ensure that products in circulation meet safety, quality, and efficacy standards, registration or notification to the BPOM must be completed before distribution. However, some products submitted for registration or notification contain new ingredients or are classified as new products. In such cases, an assessment must be conducted by the Directorate of Standardization of Traditional Medicines, Health Supplements, and Cosmetics (OTSKK).

This assessment supports the registration or notification process for products that either lack specific regulations or standards, or contain ingredients not yet listed in the ASROT and NOTIFKOS e-registration databases. It also applies to ingredients that are regulated or under consideration for regulation by the BPOM.

The safety and quality assessment of cosmetic ingredients determines their suitability for use in cosmetics. Other assessments in the field of cosmetics are conducted on cosmetic dosage forms permitted for manufacture by enterprises holding a class B production license, as well as on cosmetic products intended for sale at refill facilities.

On April 29, 2025, the Directorate of Standardization of OTSKK in Indonesia released a draft amended Regulation Concerning Service Standards for the Directorate. ¹Stakeholders are invited to submit feedback by May 10, 2025, via the following:

Online form: http://bit.ly/Masukan-RevisiYanblik2025
Email: [email protected]

Scope of the Service Standards

The Service Standards outlines services provided by the Directorate, including:

Assessment of the safety, quality, and efficacy of natural medicines, quasi-drugs, health supplements, and cosmetics;
Consultation on norms, standards, procedures, and criteria in these sectors.

Key Changes for the Cosmetics Sector

The draft amendments affecting cosmetics companies include updates to general requirements, dossier submission criteria, and assessment timeframes for assessing the safety, quality, and efficacy of cosmetics. Revised sections are highlighted in red below.

1. General Requirements

a. Applications must be submitted directly by business operators intending to notify cosmetics;

b. Intermediaries are not permitted;

c. Applications must include a formal request letter for the assessment of cosmetics.

2. Required Dossiers

Assessment Types		Required Dossiers
Safety of cosmetic ingredients	Plant ingredients	Supporting data must include: 1) Procedures and requirements follow the Guidelines for Safety Assessment of Plant Ingredients for Cosmetics; 2) Assessments as colorants, preservatives, or sunscreens for cosmetics made in Indonesia can only be submitted for cosmetic ingredients in the form of plants in Indonesia. Procedures and requirements follow the Guidelines for Safety Assessment of Plant Ingredients for Cosmetics and must be accompanied by efficacy data using valid and current methodologies; 3) Results of independent ingredient safety assessments.
	Non-plant cosmetic ingredients	Supporting data must include: 1) Physicochemical characteristics; 2) Intended function; 3) Concentration in finished products (%); 4) Application method (rinse-off or leave-on); 5) Exposure type (e.g., oral, dermal, inhalation); 6) Toxicological data relevant to the usage; 7) Ingredient exposure information; 8) Regulatory and usage status in other countries (if available); 9) Reporting data on side effects of cosmetics containing the ingredient (if applicable); 10) Supporting safety data from scientific publications; 11) For nanomaterials, also provide: a. Absorption and particle size data b. Safety, efficacy, and quality data 12) Assessments as colorants, preservatives, or sunscreen ingredients for cosmetics made in Indonesia can only be submitted for cosmetic ingredients in the form of natural ingredients (other than plants) in Indonesia. In addition to safety and quality documents, it must also be equipped with efficacy data using valid and current methodologies; 13) Results of independent ingredient safety assessments.
Forms and types of preparations that can be produced by the cosmetic production enterprise with class B production licenses		Supporting documents must include: 1) Cosmetic formula; 2) Manufacturing method; 3) Dosage form; 4) Product usage; 5) BPOM-approved production facilities; 6) Product photos (if available); 7) Summary of supporting data.
Cosmetic sales at cosmetic refill facilities		The required dossiers remain unchanged.

3. Introduction of a Fast-Track Assessment Process

In addition to the regular application, the draft introduces a fast-track assessment. Fast-track assessment is available for cosmetic ingredients that meet the following criteria:

a. Plant-based cosmetic ingredients:

The simplicia or all mixed simplicia are already listed in the NOTIFKOS database;
There is empirical evidence of safe use on the skin, aligned with the intended method of application;
Have skin and eye irritation test data, as well as skin sensitization test data;
The ingredient is listed in the NOTIFKOS database but the INCI name has changed;
The ingredient is already regulated as a cosmetic ingredient in other countries.

b. Non-plant cosmetic ingredients:

A safety assessment report is available from recognized scientific bodies, such as the EU Scientific Committee on Consumer Safety (SCCS) or the US Cosmetic Ingredient Review (CIR);
The ingredient is listed in the NOTIFKOS database but the INCI name has changed.

The steps for regular and fast-track assessments are similar, but the processing timeframes differ.

1) Steps

a. Applicants submit their assessment request via http://standar-otskk.pom.go.id

b. The Directorate checks for document completeness. If incomplete, applicants are asked to revise.

c. If complete, the assessment is conducted and the result issued.

d. Applicants receive an official assessment response letter.

e. Applicants are invited to complete a customer satisfaction survey.

2) Timelines:

Regular assessment: up to 85 working days

Fast-track assessment: up to 10 working days