On November 2, 2026, the National Agency for Drug and Food Control of Indonesia (BPOM) published the draft Regulation on Cosmetic Forms, Preparations and Categories Permitted for Production by Class B Cosmetic Manufacturers on its dedicated portal for the standardization of pharmaceuticals, traditional medicines, cosmetics and health supplements for public consultation. Comments are due by November 20, 2026.
Once finalized, the draft will replace the existing Regulation No. 8 of 2021 of BPOM on the Dosage Forms and Preparation Types of Certain Cosmetics That Can Be Produced by Cosmetic Manufacturers Holding Class B Cosmetics Production Certificates (State Gazette of 2021 No. 177), and will take effect on the date of its promulgation.
Background
Indonesia applies classification management of Good Cosmetic Manufacturing Practice (CPKB) certificates to cosmetic manufacturers:
- Manufacturers holding Class A certificates may produce cosmetics in all dosage forms and preparation types, and their technical supervisors must be pharmacists;
- Manufacturers holding Class B certificates may only produce cosmetics with low risk factors and/or cosmetics produced with simple technologies, and their technical supervisors are pharmaceutical technical personnel (TTP).
The production scope of Class B manufacturers is delimited by the above-mentioned Regulation No. 8 of 2021 through a list based on “dosage forms + preparation types”. BPOM noted in the recitals of the draft that the dosage forms and preparation types of certain cosmetics stipulated in that regulation no longer meet current legal needs or the scientific and technological developments in the cosmetics sector, and therefore need to be replaced.
Main Revisions
The draft consists of 8 articles and one annex, and its main contents can be summarized in five aspects:
1. Expansion of regulatory dimensions
2. New definitions of terms
3. Establishment of an access pathway for categories not listed in the annex
4. Adjustment of the prohibited list
5. Detailed administrative sanctions
Regulatory dimensions expanded to dosage forms, preparation types, and product categories
Article 2 of the draft provides that Class B cosmetic manufacturers may produce cosmetics of specific dosage forms, preparation types, and product categories, provided that such products have low risk factors and/or are produced with simple technologies. The annex lists the corresponding preparation types and product categories under the four major dosage forms:
- Liquid: covering 3 preparation types (liquid, thick liquid, and suspension) and 36 product categories, including body mist, eau de cologne, eau de toilette, perfume, hair oil, facial cleanser, etc.;
- Semi-solid: covering 4 preparation types (cream, gel, pomade, and paste) and 18 product categories, including traditional scrub (lulur), massage preparations, hair creambath, hair mask, etc.;
- Powder: covering 6 preparation types (dusting powder, scrub powder, traditional scrub (lulur), bath salt, compact powder (serbuk kompak), and deodorant powder) and 11 product categories, including bath powder, face mask powder, body powder, etc.;
- Solid: covering 4 preparation types (bar soap, solid shampoo, deodorant stick, and spice-based solid preparations) and 14 product categories, with a catch-all clause allowing other solid preparations to be produced as long as they meet the safety, efficacy, and quality requirements.
New definitions
Article 1 of the draft defines two key terms for the first time:
- Simple technology: refers to technology with uncomplicated mechanical structures and operational processes, whether manually operated or using machines with basic systems, which is easy to operate, does not require high-level technical expertise, and is practical in maintenance and cleaning to prevent cross-contamination;
- Chemical peeling: refers to a cosmetic containing chemical substances used to remove dead skin cells on the face and/or neck.
Categories not listed in the annex require prior risk assessment
Article 3 of the draft provides that dosage forms, preparation types, and product categories with low risk factors and/or produced with simple technologies but not listed in the annex may only be produced after a risk assessment has been completed.
The risk assessment application is submitted by the cosmetic manufacturer to the Head of BPOM through the high-level official in charge of the standardization of natural medicines, quasi-drugs, health supplements, and cosmetics.
Adjustment of the prohibited list
Article 4 of the draft continues the prohibition provisions, specifying that Class B cosmetic manufacturers must not produce the following four categories of cosmetics:
1. Cosmetics intended for babies;
2. Cosmetics intended for use around the eyes, in the oral cavity, and/or on other mucous membranes;
3. Cosmetics falling into the categories of acne skin products, skin-lightening preparations, sunscreen preparations, chemical peeling preparations, and/or hair dyes;
4. Cosmetics requiring high technologies in their production, namely aerosols and nanotechnology products.
Compared with the current regulation:
- the wording of item 3 above has been changed from “containing substances with the corresponding functions” to a definition by “product category”;
- in item 4, compact powder products (pressed powders), which were previously listed as high-technology cases, have been moved into the permitted list in the annex, while nanotechnology products are newly added to the prohibited cases.
Implications for relevant enterprises
The draft is still at the stage of public consultation; the official document number, promulgation date, and final provisions are subject to official publication. Based on the draft, CIRS Group suggests that relevant enterprises:
- Class B certificate holders should check each of the three dimensions—dosage forms, preparation types, and product categories—against the annex of the draft before product initiation; those intending to produce categories not listed in the annex should reserve time for the risk assessment application and describe the risk profile and production process of the product in the application;
- Contract manufacturing partners (brand owners) should verify whether the production scope covered by the contract manufacturer's Class B certificate is consistent with the annex of the new regulation, so as to avoid administrative sanctions after products are placed on the market due to exceeding the permitted production scope;
- Pay attention to changes in market access for compact powder (pressed powder) products: compact powder products, which are prohibited under the current regulation, are proposed to be moved into the permitted list; relevant enterprises may assess the feasibility of such new categories based on their own process conditions, but nanotechnology products will be explicitly prohibited.
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