Indonesia Implements Criteria and Procedure for Submission of Cosmetics Notification

On June 24, 2020, Indonesia implemented the amended Criteria and Procedure for Submission of Cosmetics Notification ^[1]. The previous Criteria and Procedure for Submission of Cosmetics Notification 2010 was revoked and declared invalid.

The new regulation clarifies the definition of terms, the scope of notification applicants, dossiers necessary, notification procedures, notification template, cosmetics categories, etc. The main contents are as follows:

1. The Scope of Notification Applicant

Cosmetics industry in Indonesia
An individual business/business entity in the cosmetics field that makes a production contract with the cosmetics industry in Indonesia
Cosmetics importers (including an individual business/business entity that makes a production contract with the cosmetic industry outside Indonesia)

2. Notification Procedures

1) Applicant Registration

Notification Applicant Registration Procedures

Source: Regulation for Electronic Business Licensing of Drug and Food

Qualified applicants must first register as notification applicants with the Head of the Agency. Notification applicant registration shall be done by filling out Template and uploading electronic data via the BPOM cosmetics notification service official page. If the data submitted are verified, the applicant will get the User ID and Password to apply for the notification.

For an importer or business individual/business entity that undertakes a production contract, it must obtain a recommendation as a notification applicant. The recommendation shall be obtained by submitting an application for facilities inspection to the Head of the local UPT BPOM.

2) Notification Application

Notification Procedures

Source: Regulation for Electronic Business Licensing of Drug and Food

Registered applicants apply for notification by filling out and uploading data on the Notification Template electronically via the BPOM cosmetics notification service official page.

*All the information necessary for notification can refer to our coslist. Also you could click here to find dossiers that shall be submitted for notification.

The applicant who has successfully submitted the Template will receive an electronic Pay Order. The applicant should make a payment through an electronic payment system as non-tax state revenue within seven working days. The system issues a product ID number automatically as a receipt for the notification application (If the applicant makes the payment exceeding seven working days, the notification application will be considered null and void automatically deleted from the system).
The notification applicant will receive the cosmetic notification dossiers verification result in any of the following conditions within fourteen working days from the issue of the product ID number (For perfume products, three working days).

1. Received. The Head of the Agency will issue a notification letter stating the notification number.

2. Rejected. Fees that have been paid are irrevocable.

3. Clarification request. This result will be issued in terms of cosmetics contain ingredients with uncertain safety and usefulness or cosmetics with unclear data related to the product name, status, categories, and/or brand ownership. Clarification documents shall be supplemented within 14 working days. Clarification is carried out at most three times.

Once the product got notified, it must be manufactured or imported and circulated within six months

3. Priority Services

Priority services are provided to notification applicants who meet the following criteria. The notification dossiers verification results shall be issued within three working days under priority service.

Cosmetics industry that has been registered with BPOM and has a cosmetics notification number for sub-accounts submitted

Have never been involved in a criminal offense in the field of cosmetics

Administrative documents submitted are well-formed and in good order

Have a safety assessor/technical person in charge

Not use a service bureau in handling notification/distribution permit

Never received a warning letter related to violations and/or listed in a public warning related to prohibited ingredients and illegal cosmetics during the last two years

Never received a stern warning letter during the last two years

Conduct and report the results of cosmetics adverse reaction monitoring

Never received the rejected results of notification dossiers verification on the grounds of not meeting administrative, safety and quality requirements for the past three years

Have audited PIF and/or inspection of production facilities and/or GMP with the results of complete documents (CAPA closed)

Not use the brand together

Never involved a case related to the brand

4. Other Points of Attention

One Cosmetics Name can only be notified by one requesting notification.
The notification applicant may file a cosmetic notification with the same Cosmetic Name.
A hearing mechanism can be ordered by BPOM or requested by notification applicant before the issuance of notification dossiers verification results.
If necessary, the notification applicant shall submit cosmetics examples to BPOM.
Cosmetics with expired notification are prohibited from being produced or imported and/or distributed in Indonesian. But in cases where the notification has expired, cosmetics that have been distributed can be circulated for a maximum of 6 months under the following conditions:

Still in the process of submitting notification renewal

Still in the process of submitting new notification

Has received a new notification

5. Transitional Measures

Applications for cosmetics notifications that have been submitted before June 24, 2020 are still being processed according to previous regulation.
Cosmetics notification issued according to the previous regulation is still valid until the expiration of the notification period.