BPOM Cosmetics Registration + DIP

Cosmetics refer to materials or preparations intended for external use on the human body, such as the skin, hair, nails, lips, and external genitalia, or on teeth and the mucous membranes of the mouth. They are specifically used for cleaning, perfuming, changing appearance and/or improving body odor, or for protecting or maintaining good condition of the body.

Basic Informations

1. Cosmetics refer to materials or preparations intended for external use on the human body, such as the skin, hair, nails, lips, and external genitalia, or on teeth and the mucous membranes of the mouth. They are specifically used for cleaning, perfuming, changing appearance and/or improving body odor, or for protecting or maintaining good condition of the body.

2. Cosmetics used to improve the appearance or odor of the human body include: skincare creams, lotions, powders, perfumes, lipsticks, nail polish, facial and eye cosmetics, colored contact lenses, hair dye, hairspray, deodorants, hand wash, baby products, bath oils, shower gels, bath salts, and many other types of products. These are generally referred to as “cosmetics” and are primarily products designed to alter the user’s appearance.

3. According to BPOM regulations, products circulating in Indonesia must have a sales permit number.

4. Imported cosmetics refer to cosmetics produced by overseas factories, including both owned factories and contract manufacturers. Local cosmetics refer to cosmetics produced by domestic factories, which can either be owned factories or local OEM factories.

5. Any cosmetic product must obtain approval from the BPOM agency before distribution in Indonesia, known as the BPOM Notification Number (NIE). However, cosmetics intended for research or exhibition purposes (limited quantity and non-sale) do not require registration for BPOM product distribution numbers.

6. Cosmetics circulating in Indonesia must meet the following conditions:

(1) The cosmetics must be safe and not cause harm or danger to human health under normal or expected use conditions.

(2) The availability of the product must be evaluated according to the intended use and claims, meeting legal requirements.

(3) The quality must meet Indonesian standards for cosmetics.

(4) Labels must contain complete, accurate, and non-misleading information. Information on usage, instructions, warnings, and other required details must be provided in the Indonesian language.

7. The container and/or packaging label must include the following information:

(1) Product name;

(2) Manufacturer’s name and the address of the importer/distributor;

(3) Size, content, or net weight;

(4) Ingredients (must comply with Indonesian cosmetic regulations or other applicable terms);

(5) BPOM Number;

(6) Batch number/production code;

(7) Purpose and usage instructions;

(8) Product expiration date;

(9) Other labels related to safety and/or quality.

8. The business scope for imported cosmetics is as follows:

Business Scope	Activity Classification	Description
46443	Wholesale Trade of Human Cosmetics	This category includes wholesale trade of human cosmetics such as perfumes, soaps, powders, etc.

9. The BPOM cosmetics distribution number is valid for 3 years or according to the validity period of the LOA/MOU. The company can extend the BPOM sales permit number at least 1 month before its expiration.

10. After obtaining the BPOM product distribution license, each time goods are imported, an import certificate (BPOM SKI) must be submitted.

Processing Time & Required Documents

Processing Time : 3 Months

Required Documents :

· Chapter 1: Administrative DocumentsBusiness Registration Certificate (API-U)

1. Business Registration Certificate

2. Cooperation Agreement between Factory and Importer / Certificate of Free Sale

3. GMP / ISO 22716

4. Indonesian Trademark Certificate / Trademark Registration Certificate

5. Warehouse Inspection Result Report

6. Director’s Declaration of No Criminal Record

· Chapter 2: Quality and Safety Data of Cosmetic IngredientsBusiness Registration Certificate (API-U)

1. Specifications and COA (Certificate of Analysis) for each material

2. COO (Certificate of Origin) and Production Flow Diagram

3. Analytical methods that comply with the specifications of each material

4. Material Safety Data:

– Data provided by the supplier

– Official and scientific data

– Supporting documents: journals, papers, or product test reports

· Chapter 3: Finished Product Quality Data

1. Cosmetic Ingredient List:

– Contains INCI (International Nomenclature of Cosmetic Ingredients) names

– Lists material functions

– Total percentage is 100%

2. Name, address, and country/region of the factory involved in processing and packaging

3. Production Flow Diagram

4. Additional information about the production process (if available)

5. Production batch number description

6. Cosmetic Specifications:

– Contamination control

– Purity of product ingredients

– Compliance with required regulations

7. Analytical methods conforming to cosmetic standards

8. Cosmetic stability data (expiration determination and stability test data)

· Chapter 4: Safety and Efficacy Data

1. Cosmetic Safety Assessment Report

2. Resume of the Technical Person in Charge (PJT)

3. Cosmetic Side Effect Monitoring Results

4. Cosmetic Claims Supporting Documents

5. Cosmetic Labeling and Advertising:

– Primary and secondary packaging

– Manuals and labels (if available)

– Labeling

6. Other Data / Product History Records