Regulation for Cosmetics Adverse Reaction Monitoring

On November 9, 2023, Indonesia released the amended draft of the Regulation for Cosmetics Adverse Reaction Monitoring for public consultation. 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.

Monitoring cosmetics adverse reactions are activities that include recording, data collection, reporting, evaluation, prevention and follow-up on effects in the form of undesirable events that arise due to/during the use of cosmetics.

Main Content

1. General Requirements

2. Application

3. Reporting Procedures

4. Documentation

5. Administrative Sanctions

6. Closing

7. Annex I Thirty Hair Dyeing Agents

Annex II Quick Reporting Form

Annex III Monitoring Reporting Form for Cosmetic Adverse Reactions

Instructions for Filling Monitoring Reporting Form for Cosmetic Adverse Reactions

Annex IV Recapitulation Table of Monitoring Results of Cosmetic Adverse Reactions

Instructions for Filling the Recapitulation Table of Monitoring Results of Cosmetic Adverse Reactions