The main amendments include the following:

1) Refining the process and requirements for applying for the “letter of recommendation as a notification applicant”;

2) Clarifying the requirements for products with multiple production sites or commissioned manufacturers in Indonesia;

3) Adding a situation that allows the use of previously notified cosmetic product names;

4) Slightly amending the requirements for mandatory documents for cosmetic notification application;

5) Adding a situation that allows applicants to apply for notification information changes, and clarifying the application process.

On Dec. 6, 2021, Indonesia Food and Drug Supervisory Agency (BPOM) issued a revised draft of the Procedure for Submission of Cosmetics Notification for public consultation. On Oct. 5, 2022, Indonesia issued and implemented the revised Procedure for Submission of Cosmetics Notification (hereafter referred to as the "Regulation"), replacing the 2020 version. ¹

The Regulation provides criteria and procedures for companies to refer to when applying for cosmetics notification in Indonesia. Notification applications submitted before Oct. 5, 2022, will still be processed in accordance with the 2020 version. Cosmetic notification numbers obtained before Oct. 5, 2022, are still valid until the expiration date.

The Regulation is divided into 7 chapters and 56 articles with 5 appendices, which stipulates the scope of notification applicants, the documents required for notification, notification procedures, cosmetic product categories, etc. The main amendments are as follows:

1. Refining the process and requirements for applying for the letter of recommendation as a notification applicant

Before applying for notification, companies that commission other companies to produce cosmetics (hereafter referred to as "commissioning manufacturers") or importers must apply to the local UPT BPOM for on-site inspection, so as to obtain the letter of recommendation as a notification applicant. If the commissioning manufacturer or the importer is also an Indonesian cosmetic company, the recommendation letter can be exempted.

The Regulation refines the requirements for importers and commissioning manufacturers. The newly added Appendix IV details the application process for the recommendation letter, on-site inspection items, templates for inspection result letter, and recommendation letter revocation statement, etc.

2. Clarifying the requirements for products with multiple production sites or commissioned manufacturers in Indonesia

The Regulation clarifies that for the same product with multiple production sites in Indonesia, or the same product that the brand commissioned multiple Indonesian factories to produce, as long as the product is similar in all the following aspects, the brand is allowed to apply for one notification number.

• Product name
• Product formula
• Ingredient specifications
• Packaging material specifications
• Finished product specifications
• Production process
• Label design

3. Adding a situation that allows the use of previously notified cosmetic product names

When applying for cosmetic notification, the notification applicant shall not use the same name as previously notified products. However, if a new notification application is submitted by the affiliated company to the company owning the previously notified product, the name of the previously notified product can be used. A statement letter proving the affiliation issued by the parent company and an approval letter issued by the owner of the previously notified cosmetics are required.

The Regulation adds a situation that allows the use of previously notified cosmetic product names for the notification of the same product for different target markets. An approval letter issued by the owner of the previously notified cosmetics is required.

4. Slightly amending the requirements for mandatory documents for cosmetic notification application

1) Relaxing the requirements for the remaining validity period of GMP certificate, the fulfillment certificate for GMP aspects, and the statement letter for implementing GMP, from at least six months to at least three months;

2) Revising the document legalization requirements for GMP certificate and CFS certificate.

Notes: The Convention of Oct. 5, 1961 Abolishing the Requirement of Legalization for Foreign Public Documents, also known as the Apostille Convention, is an international treaty drafted by the Hague Conference on Private International Law (HCCH). It is intended to simplify the procedure through which a document, issued in one of the contracting states, can be certified for legal purposes in all other contracting states. A certification under the Convention is called an apostille or Hague apostille. Apostille Convention is an international certification comparable to notarization, and may supplement local notarization of the document. If the Convention applies between two states, an apostille issued by the state of origin is sufficient to certify the document, and the need for further certification by the destination state is removed. The Apostille Convention entered into force in Indonesia on June 4, 2022.

5. Adding a situation that allows applicants to apply for notification information changes, and clarifying the application process

The situations that allow applicants to apply for notification information changes are increased from the previous three to four, shown in the below table. The Regulation also clarifies the application process for notification information changes.

6. Other noteworthy points

• The Regulation clarifies that cosmetics for export only do not require notification in Indonesia;
• The Regulation adds notification application procedures for cosmetic product set;
• The Regulation does not modify the procedures of cosmetic notification.

Further Reading

• Indonesia Amends Labeling Requirements for 2D Barcode on Cosmetics
• Indonesia Consults on the Draft Regulation for Perfume Refill
• Indonesia Implements the Amended Cosmetic Ingredient Use Requirements: 17 Newly Permitted Ingredients and 231 Newly Prohibited Ingredients
• WTO Circulates Indonesian Decree on Materials Exempted from Mandatory Halal Certification

Reference Links

[1] Indonesia Implements the Amended Procedure for Submission of Cosmetics Notification

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