Indonesia Proposes Amendments to Cosmetic Notification Requirements

Terms:

1. Bulk products are processed materials that only require packaging to become finished products;

2. Good manufacturing practice (GMP) certificate is a legal document serving as a proof that the cosmetic enterprise has fully implemented GMP in the manufacture of cosmetics;

3. Certificate of GMP Fulfillment is a legal document serving as a proof that the cosmetic enterprise has gradually implemented GMP. The Certificate is divided into Class A and Class B. Class A is applicable to enterprises that can produce all types of cosmetics, while Class B is applicable to enterprises that can only produce certain types of cosmetics. Class A requires enterprises’ compliance in 10 aspects in GMP, while Class B requires compliance in 2 aspects in GMP.

On December 9, 2024, the Indonesian Food and Drug Supervisory Agency (BPOM) released a draft amended Regulation Concerning the Procedure for Submission of Cosmetics Notification for public consultation. ¹ Below is a summary of the key changes that will impact cosmetic companies looking to import products into Indonesia, with newly added category highlighted in red.

1. Refining scope of products requiring cosmetic notification

The categories subject to notification include:

a. Indonesian domestic cosmetics;

b. Locally produced cosmetics commissioned by Indonesian companies;

c. Foreign-produced cosmetics commissioned by Indonesian companies;

d. Licensed cosmetics produced by Indonesian companies under a license;

e. Imported cosmetics;

f. Exported cosmetics;

g. Kit cosmetics.

For the newly added category, a license is a permit granted by the licensor to the licensee through a written agreement, allowing the use of research and development results related to safety, efficacy, quality, and/or technology transfer in the manufacture and sale of cosmetics. The draft Regulation also introduces requirements for applying for notification for licensed cosmetics.

2. Modifying the documentary requirements for cosmetic notification applicants

The documentary requirements for notification applicants of imported cosmetics are listed in the table below, with newly added or modified documents highlighted in red.

Documents	Document Requirements
A stamped statement from the board of directors and/or management affirming that they are not involved in any criminal activities related to cosmetics	/
A letter of recommendation as the notification applicant from the Head of the local BPOM UPT	/
A valid agency appointment letter with at least six months of remaining validity, in Indonesian and/or English	The letter must include at least the following information: 1. Name and address of the manufacturer/principal in the country of origin; 2. Name of the importer; 3. Brand and/or name of the cosmetics; 4. Date of issue; 5. Validity period of the agency appointment; 6. Rights to notification, import, and distribution granted by the manufacturer/principal; 7. Name and signature of the director/leader of the manufacturer/principal of the country of origin.
Certificate of Free Sale (CFS) for imported cosmetics from non-ASEAN countries, issued by an authorized official or recognized institution in the country of origin, except for contract cosmetics produced outside Indonesia.	The certificate must be legalized with an Apostille by an authorized official in the country of origin. If the product comes from a country not being a party to the convention on the elimination of legalization requirements for foreign public documents, it must be legalized by the local Embassy or Consulate General of the Republic of Indonesia.
A GMP certificate or a statement of GMP application for companies located in ASEAN countries	The certificate or statement must meet the following requirements: 1. The remaining validity period must be at least three months; 2. If the validity period exceeds five years or is unspecified, the certificate or statement is considered valid for five years from the date of issuance.
A GMP certificate for: 1. Cosmetics companies located outside ASEAN countries; 2. ASEAN cosmetics companies that have production contracts with Indonesian local companies.	The certificate must meet the following requirements: 1. Issued by an authorized government official or recognized institution in the country of origin, supported by a statement from the relevant government authority; 2. The remaining validity period must be at least three months; 3. If the validity period exceeds five years or is unspecified, the certificate is considered valid for five years from the date of issuance. The certificate must be legalized with an Apostille by an authorized official in the country of origin. If the product is from a country not being a party to the convention on the elimination of legalization requirements for foreign public documents, it must be legalized by the local Embassy or Consulate General of the Republic of Indonesia. If a GMP certificate cannot be provided, the importer must attach a certification document of GMP recognized as equivalent to ASEAN GMP and duly legalized.
A photocopy of the trademark certificate registered under the name of the notification applicant, or a proof of trademark registration in the name of the notification applicant if the notification applicant does not yet have a trademark certificate	If the registered trademark owner listed on the cosmetic trademark certificate is not the notification applicant, the following must be provided: 1. A statement detailing the relationship between the registered trademark owner and the notification applicant; 2. A copy of the company deed that provides information about their relationship.
A stamped statement confirming that the notification applicant agrees to cancel their notification number if: 1. Another party holds greater rights to the trademark and/or cosmetic name; or 2. The trademark registration application is rejected.	/
Note: The importer must have a technical person who understands the Product Information File (PIF) and related technical information of cosmetics.

3. Adding a situation where requires data updates for the recommendation as a notification applicant

Importers or business entities engaged in a production contract must obtain a recommendation as a notification applicant. This recommendation is secured by submitting a facilities inspection application to the Head of the local UPT BPOM. The application for the recommendation letter need only be submitted once; however, if any of the following data changes, the notification applicant must resubmit the application or request data updates. Newly added situation is marked in red.

Changes	Requirements
Changes to the company address and/or warehouse address	Resubmitting the application for recommendation letter
Addition of warehouse addresses Changes to the business entity name, legal entity, or type of business Updates to the company and/or warehouse address without changing the location Changes to company management, directors, or the technical person in charge	Requesting data updates

4. Revising requirements for notification validity period

The notification is valid for a maximum of three years and can be renewed. The draft Regulation adds that for imported cosmetics, contract cosmetics, or licensed cosmetics with an agency appointment letter, production contract, or license agreement validity of less than three years, the notification validity should be consistent with the duration of these documents.

5. Other amendments

1. The draft Regulation clarifies that bulk products ready for primary packaging by Indonesian domestic companies must be notified as imported products. This notification must be submitted by domestic companies in Indonesia that hold GMP certificates or certificates of GMP fulfillment;

2. After the notification document is submitted, BPOM will review it. If additional documents are required, BPOM will verify them within 14 working days. The draft removes the provision allowing BPOM an additional 7 working days for review;

3. In the event of changes to the notification documents, the notification applicant must update the information through the official BPOM Notification service page. BPOM will verify the information update within seven working days of submission via this page.