Indonesia BPOM Unveils the 2024 Legislative Plan, Involving Cosmetic Notification, Labeling, Ingredient Requirements, Adverse Reaction Monitoring, Contamination Limits

1

Draft Amendment to BPOM Regulation No. 21 of 2022 Concerning Procedures for Submission of Cosmetic Notification

October 5, 2022

Several provisions require adjustment to align with the latest developments in the cosmetic sector. These adjustments include clarifying the time frame for response, as well as incorporating cosmetic ingredient concentration in the notification template and brand license agreement.

2

Draft BPOM Regulation Concerning Technical Requirements for Cosmetic Labeling

November 9, 2023 (Draft)

1. Clarifying that the requirement of non-halal information labeling applies only to products that contain ingredients prohibited in halal products;

2. Differentiating between halal and non-halal ingredients during the cosmetic processing process.

3

Draft BPOM Regulation Concerning Cosmetics Adverse Reaction Monitoring

November 9, 2023 (Draft)

Several provisions regarding adverse reaction monitoring mechanism require adjustment to align with the latest developments in the cosmetic sector.

4

Draft Amendment to BPOM Regulation No. 33 of 2021 Concerning Cosmetic Good Manufacturing Practices Certification

December 31, 2021

The revision encompasses, but is not limited to:

1. Requirements for applying for approval to use cosmetic production facilities together with quasi-drugs;

2. Procedures for submitting applications for approval to use cosmetic production facilities together with quasi-drugs;

3. Administrative sanctions for enterprises that fail to comply with the regulations.

5

Draft BPOM Regulation Concerning Limitations for Contamination in Cosmetics

November 9, 2023 (Draft)

The revision encompasses, but is not limited to:

1. Types of cosmetic contamination;

2. Contamination and testing limits;

3. Administrative sanctions for enterprises that fail to comply with the regulations.

6

Amendments to BPOM Regulation No. 19 of 2021 Concerning Guidelines for Follow-up on Supervision Results of Traditional Medicines, Quasi-drugs, Health Supplements and Cosmetics

July 13, 2021

1. Adjustments need to be made to EG (ethylene glycol) and DEG (diethylene glycol), given practices involving EG and DEG, as well as supervision results that require follow-up, which have not been addressed in the current regulation;

2. Adjustments need to be made in line with the newly issued BPOM Regulation No. 16 of 2023 on the Supervision of Traditional Medicines, Quasi-drugs, and Health Supplements Distribution, and BPOM Regulation No. 12 of 2023 Concerning Supervision on Manufacture and Circulation of Cosmetics.

7

Amendments to BPOM Regulation Concerning the Control of Drug and Food Online Distribution

January 22, 2024 (Draft)

Adjustments need to be made in line with the newly issued

• Minister of Health Regulation No. 14 of 2021 Concerning Standards for Business Activities and Products in the Implementation of Risk-based Business Licensing in the Health Sector;

• Minister of Trade Regulation No. 31 of 2023 Concerning Business Licensing, Advertising, Guidance and Supervision of Businesses in Trading Through Electronic Systems.

8

Draft BPOM Regulation Concerning Technical Requirements for Cosmetic Ingredients

March 1, 2024 (Draft)

This regulation will be revised to harmonize with the amendments made to the ingredient annexes of the ASEAN Cosmetic Directive (ACD) during the biannual meetings of the ASEAN Cosmetic Scientific Body (ACSB).

9

Draft Amendments to BPOM Regulation Concerning Procedures of the Clinical Trial Approval (Cosmetic Substances)

December 29, 2015

There is a need for specific cosmetic clinical trial guidelines that can serve as a reference for BPOM officers in evaluating the supporting data for cosmetic testing, as well as for businesses in planning and conducting cosmetic clinical trials. The guidelines will cover the following aspects:

• Requirements and documentation for conducting cosmetic clinical trials;

• Procedures for submitting applications for approval of cosmetic clinical trials;

• Provisions pertaining to cosmetic clinical trials.

10

Draft BPOM Regulation Concerning Risk Assessment of Additional Ingredients Used in Certain Preparations of Natural Medicines, Quasi-drugs, Health Supplements and Cosmetics

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1. Adjustments need to be made to EG (ethylene glycol) and DEG (diethylene glycol) in additional ingredients in certain preparations;

2. As a follow-up to the Draft Government Regulation on the Implementation of Law Number 17 of 2023 on Health, it is necessary to establish a regulation regarding pharmaceutical ingredients for certain preparations of natural medicines and health supplements;

3. Proposing quality standards and/or requirements for pharmaceutical ingredients that those used in certain preparations of natural medicines and health supplements must comply with.

The regulation will encompass the following aspects:

• Criteria for conducting risk assessments on specific preparations;

• List of additional ingredients for specific preparations that must comply with quality standards and/or requirements as pharmaceutical ingredients.

11

Draft BPOM Regulation Concerning the Revocation of BPOM Regulation No. 26 of 2018 Concerning Electronic Business Licensing Services Integration in Drug and Food Sector

January 4, 2024 (Draft)

BPOM Regulation No. 26 of 2018 is no longer aligned with current legal developments, so it needs to be revoked.