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Indonesia to Update the list of Permitted Nutrients in Health Supplements with Restrictions

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

  • For pregnant and breastfeeding women, the maximum limit is 60 mcg/day

  • Selenium shall be in elemental form

  • For pregnant and breastfeeding women, the maximum limit is 65 mcg/day in combination form

  • Selenium shall be in elemental form

Zinc

30 mg

  • Shall be used in combination and not as a single   composition

  • Shall be used in combination

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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