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Editor's note: This article was originally published on April 11, 2024, and was updated on September 24, 2024, as per the latest developments.
On September 18, 2024, Indonesia BPOM enacted BPOM Regulation No. 15 of 2024 on Amendments to BPOM Regulation No. 32 of 2022 on Criteria and Administration of Health Supplement Registration with immediate effect. The amendment introduces same changes as in the draft version.
The registration applications for selenium supplements for pregnant and breastfeeding mothers, submitted prior to the promulgation of this regulation, shall be processed in accordance with BPOM Regulation No. 32 of 2022.
On April 3, 2024, Indonesia BPOM revealed a drafted amendment to BPOM Regulation No.32 of 2022 on Criteria and Administration of Health Supplement Registration. The proposed amendment mainly revises the list of vitamins, minerals, amino acids and other ingredients permitted for use in health supplements with restrictions in Annex VII.
The proposed changes in Annex VII
Nutrient | Daily take limit | Note (current) | Note (proposed) |
Selenium | 0.2 mg |
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Zinc | 30 mg |
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The revisions will impact the usage of Selenium and Zinc, which are vital nutrients for pregnant and breastfeeding women. Once the draft is officially implemented, the changes will come into effect immediately. However, until that happens, registration applications for health supplements designed for pregnant and breastfeeding women will continue to be processed based on the current regulation, which outlines more specific requirements regarding the permissible limits of nutrient usage in health supplements.
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