Indonesian Cosmetics Definition

According to BPOM No. 21 of 2022 "Procedural Guidelines for Submitting Cosmetic Notifications", cosmetics are defined as: products that come into contact with various external organs of the human body, such as the epidermis, hair system, nails, lips and external genitals , or in the oral cavity Teeth and oral mucosa ; substances and preparations whose main purpose (sole or main function) is to clean, aromatize (scent), improve appearance, improve body odor or protect the body and keep it in good condition.

Regulatory Background

Cosmetics are strictly controlled special commodities in Indonesia, and the competent authority is the Badan Pengawas Obat dan Makanan (BPOM). Indonesia uses the "ASEAN Cosmetics Directive" as a benchmark and combines its own laws and regulations to formulate its own cosmetics-related laws and regulations.

In order to cooperate with the latest development of the cosmetics industry , BPOM issued Document No. 21, the "Procedural Guidelines for Submitting Cosmetic Notifications", and Document No. 17, the "Cosmetics Product Information File (PIF/DIP)" in 2022 and 2023 respectively. )guide". Accordingly, cosmetics sold in Indonesia must submit product registration (Notifikasi) before listing and obtain approval from the BPOM department before they can be circulated in the market.

At the same time, within 6 months to 1 year after the product has obtained the BPOM number, the manufacturer needs to prepare a product information document for BPOM review. The purpose of the DIP audit is to track the regulatory results during the product circulation period (post market).

Registration Process

Information Required for Registration

1. Business Entity Account Registration

a. Business Registration Certificate

b. Recommendation letter issued by local UPT BPOM

c. Copy of Letter of Authorization (LoA) - notarization by embassy is not required

d. A copy of the cooperation agreement between the filing applicant and an overseas cosmetics company in Indonesia (applicable to cases where overseas production is entrusted)

e. Copy of Certificate of Free Sale CFS (need to be notarized by the embassy)

f. Cosmetics production license (if required)

g. Copy of GMP certificate (need to be notarized by the embassy)

2. Product registration (Notification)

Information needed to prepare:

1)  Registration form

2）Product Formula

3）Labels, internal and external packaging pictures (Primary & Secondary Package Design)

4）COA of Finished Product

5)  Stability Assessment, etc.

6)  Other information that may be needed

Registration Cycle

Account registration: about 1 month

Product registration: about 1-2 months

Registration validity period: 3 years, which can be extended upon expiration. After the product is registered, it needs to be produced or imported for circulation within 6 months.

Product Information Document (Dokumen Informasi Produk，DIP)

DIP includes the following four parts:

1.  Administrative documents

2.  Cosmetic ingredient quality and safety data— raw material quality and safety information

3.  Product quality and safety data

4.    Product safety and effectiveness data - such as security assessment report, test reports, efficacy reports, etc.

Other possible data

Professional Services Provided by ZOOP

1. Provide a local agent, that is, the filing entity;

2. Account registration service;

3. Packaging, labeling, and formula review services;

4. Product filing services (review, filing and submission);

5. DIP review and organizing services;

6. Product testing services

Why choose us?

1. 14 years of rich experience in compliance, a professional and mature team, and a guaranteed service cycle ;

2. Reasonable price and high-quality service throughout;

3. Outlets in Shenzhen, Guangzhou, Shanghai and Beijing, based in China and serving the world ;

4. One-stop service for makeup, disinfection and medical device, efficient and cost-effective;

5. We can directly contact with clients without language barriers to satisfy the needs of communication with overseas customers. ;

Choose ZOOP, choose trust!