Indonesia Proposes to Amend Cosmetic Adverse Reaction Reporting Requirements

Term:

Refillable cosmetics: It refers to cosmetics that are repackaged into containers according to consumer's request, which is done at cosmetic refill facilities.

On November 9, 2023, Indonesia released the amended draft of the Regulation for Cosmetics Adverse Reaction Monitoring for public consultation. ¹ This Regulation aims to provide clarity on the requirements for reporting cosmetics adverse reactions. It defines the adverse reactions, specifies the obligations of notifiers, and outlines the approaches for reporting adverse reactions.

The amended draft introduces changes to specific reporting requirements. The proposed amendments include:

1. Covering refillable cosmetics within the scope of the Regulation. Cosmetic notifiers are required to report adverse reactions related to refillable cosmetics.

2. Amending the submission methods for reporting adverse reactions

Submitted Items

Submission Method

Adverse reactions resulting in death or life-threatening situations

a. e-reporting;

b. electronic mail;

c. telephone;

d. facsimile.

Detailed documents of adverse reactions resulting in death or life-threatening situations;
Adverse reactions requiring hospitalization or causing permanent disability;
Reporting of non-serious adverse reactions;
Reporting of adverse reactions from cosmetics containing hair dyeing agents listed in Annex 1 of the Regulation.

a. e-reporting;

b. electronic mail;

c. facsimile.

3. Amending the administrative sanctions imposed on cosmetic notifiers who violate the Regulation. The potential administrative sanctions include:

Written warning;
Temporary ban on distributing cosmetics for up to one year;
Temporary suspension of product sales;
Temporary closure of online access to apply for import certificates for up to one year;
Temporary closure of notification access;
Revocation of the notification number.

Indonesia Proposes to Amend Cosmetic Adverse Reaction Reporting Requirements

Further Reading