Indonesia BPOM Unveils Food Legislation Plan for 2024, Involving Processed Food and Health Supplements

1

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

The existing/current version of the Regulation no longer aligns with current legal developments, so it needs to be revoked.

2

Draft BPOM Regulation on the Inclusion of Information on the Origin of Ingredients in Product Information and/or Labels

It aims to provide a legal basis for business actors who produce and/or import food products for distribution in the Indonesian territory, that information on the origin of ingredients shall be included before the food product is distributed in the Indonesian territory.

3

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

With the issuance of Minister of Health Regulation No. 14 of 2021 on Standards for Business Activities and Products in the Implementation of Risk-based Business Licensing in the Health Sector and Minister of Trade Regulation No. 31 of 2023 on Business Licensing, Advertising, Guidance and Supervision of Businesses in Trading Through Electronic Systems, adjustments need to be made to BPOM Regulation on the Control of Drug and Food Online Distribution.

1

Draft BPOM Regulation on the Withdrawal and Destruction of Natural Medicines, Quasi-Medicines and Health Supplements that Do Not Meet the Standards and/or Requirements for Safety, Efficacy/Benefits, Quality, Marking and Advertising

As there is no reference for the withdrawal and destruction of quasi-medicines and health supplements that do not meet the requirements, this Regulation aims to fill the regulatory gap. The Regulation covers:

1. Criteria

2. Withdrawal Procedures

3. Extermination

4. Sanctions

2

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

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.

3

Amendments to BPOM Regulation No. 16 of 2019 on Supervision of Health Supplements

With the issuance of BPOM Regulation No. 16 of 2023 on Supervision of the Distribution of Traditional Medicines, Quasi Medicines and Health Supplements and other related regulations, adjustments need to be made to requirements regarding the manufacturing facilities, sanctions, and side effect monitoring mechanism. The revised regulation is set to be a guide for both business actors and BPOM officers in carrying out pre-market and post-market supervision on aspects including production facilities.

4

Draft Amendments to BPOM Regulation No. 17 of 2021 on Guidelines for Assessment of Health Supplement Products Containing Probiotics

Based on the assessment and analysis of the effectiveness of BPOM Regulation No. 17 of 2021 on Guidelines for Assessment of Health Supplement Products Containing Probiotics, there are several provisions that have not been clearly described to solve the problems faced by business actors, such asthe safety, benefit and quality data of probiotic strains; clinical trials of new probiotic strains; permitted claims and labels and markings.

The revision will serve as technical guidelines regarding the types of supporting data and evaluations carried out in relation to:

1. safety, efficacy and quality data of probiotic strains;

2. clinical trials of new probiotic strains;

3. permitted claims; and

4. labels and markings.

5

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

There are cases involving EG (ethylene glycol) and DEG (diethylene glycol), as well as supervision results that require follow-up, which have not been addressed in the current regulation.

Besides, with the issuance of BPOM Regulation No. 16 of 2023 on the Supervision of Traditional Medicines, Quasi-drugs, and Health Supplements Distribution, adjustments need to be made to BPOM Regulation No. 19 of 2021.

6

Draft BPOM Regulation on Guidelines for Stability Testing of Health Supplements

In line with the development of ASEAN harmonization results in the field of health supplements, as well as BPOM Regulation No. 17 of 2019 on Quality Requirements for Health Supplements, this Guidelines needs to be formulated.

This Guidelines covers:

1. Design stability test;

2. Evaluation;

3. Statement on marking.

7

Draft BPOM Regulation on Marking of Natural Medicines, Quasi-Medicines and Health Supplements

Currently there are still no specific regulations that regulate in detail the labeling of natural medicines, quasi-medicines or health supplements. The general marking regulations of the three types of commodities are placed separately in regulations regarding the criteria and registration procedures for each commodity. Therefore, it is necessary to simplify the existing regulations and formulate new regulations governing the labeling of the three types of commodities, to make them clear, complete and comprehensive.

The Regulation is comprised of the following chapters:

1. General provisions;

2. Marking criteria;

3. Minimum information that must be included on the label;

4. Guidance;

5. Prohibited information;

6. Administrative sanctions.

8

Draft Amendments to BPOM Regulation No. 32 of 2022 on Criteria and Procedures for Registration of Health Supplements

The existing/current version of the Regulation specifies that the maximum limit of selenium for pregnant women is 60 μg/day, which does not conform with the new scientific results. Therefore, it is necessary to adjust the regulation and provide a legal basis for setting selenium limits in health supplements for pregnant and breastfeeding women as 65μg/day.

1

Draft Amendments to BPOM Regulation No. 27 of 2021 on Requirements for Low Acid Processed Food to be Packaged Hermetically

To address challenges faced by businesses in conducting mandatory challenge tests for low acid processed foods packaged hermetically through barrier technology, this revision will establish an exception to the challenge test requirement, targeting to facilitate businesses, particularly MSMEs, on the basis of ensuring the safety of commercial sterile food.

2

Draft Amendments to BPOM Regulation No. 20 of 2019 on Food Packaging

To align with developments in science and technology, it is necessary to review policies regarding food contact substances and their migration test limits. The Regulation covers food contact substances, food contact materials, testing of food packaging, as well as applications for use permits.

3

Draft Amendments to BPOM Regulation No. 6 of 2018 on Genetically Engineered Products

Due to the development of genetic engineering technology, BPOM aims to amend BPOM Regulation No. 6 of 2018 on Genetically Engineered Products, tightening the supervision over genetically engineered products, such as the inclusion of non-genetically engineered product (non-PRG) labels.

4

Draft Amendments to BPOM Regulation No. 26 of 2021 on Nutritional Value Information on Processed Food Labels

To support reducing the risk of Non-Communicable Diseases (NCDs) through efforts to encourage the production and consumption of processed foods low in sugar, salt and fat (GGL), also to increase the effectiveness of the Front of Pack Nutrition Labelling (FOPNL) system, revisions need to be made to BPOM Regulation No. 26 of 2021 on Nutritional Value Information on Processed Food Labels.