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On November 28 2024, Indonesia BPOM unveiled BPOM Regulation No. 19 of 2024 on Supervision of Genetically Engineered Food Products, repealing BPOM Regulation No. 6 of 2018 and taking effect immediately. The updated regulation applies to all genetically engineered (PRG) food products sold in the Indonesian market. Compared to the previous regulations, key updates and changes are outlined as follows:
1. New exemption from safety approval requirement
Businesses producing or importing PRG food for retail sale in Indonesia must apply for PRG food safety approval in principle. However, the new regulation exempts PRG food that is purified, non-protein-based, and free of PRG DNA and/or PRG proteins. Such PRG food are allowed to be in the form of oil, fat, sugar, or starch.
2. New requirements for genome editing
The new regulation newly sets forth the definition of and requirements for genome editing. Genome editing is described as a biotechnology technique enabling simpler, more precise, and efficient gene or genome modifications to produce superior food products. Food produced through genome editing process can be either PRG-PG or non-PRG food, depending on the determination made by the Commission on Biosafety of Genetically Engineered Products (KKH PRG). In particular, if a food falls under the PRG-PG food category, it is required to secure food safety approval, similar to PRG food.
3. Safety approval for a new type of PRG food
In addition to regular PRG food products, the regulation outlines safety approval guidelines in Annex 2 for PRG food resulted from conventional crossbreeding of PRG lines.
4. New requirements for the use of a new type of PRG food
PRG food produced with purified PRG microorganisms can only be circulated with prior written approval from BPOM. Businesses must follow the application process outlined in Annex 5 to secure this approval.
5. New requirements for the transfer of PRG food safety approval
The regulation allows the transfer of PRG food safety approval certificates to a third party. Applicants must submit a transfer request to BPOM following the format specified in Annex 3. Upon approval, BPOM will issue a new PRG food safety certificate to the transferee, as detailed in Annex 4.
6. Updates for PRG food label
All PRG food products sold in retail packaging must bear a special label. Notably, the regulation clarifies that fresh PRG food is excluded.
7. New requirements for post-market supervision
The regulation emphasizes stricter post-market monitoring. If PRG food products already on the market are found to negatively affect human health, the following measures will be applied:
Revocation of the PRG food safety approval, by BPOM;
Implementation of control and mitigation measures, including product recalls, by the businesses.
PRG food products already on the market before the regulation's issuance must comply with the new requirements within 12 months upon the implementation of the regulation. Existing PRG food safety approvals shall remain valid unless they conflict with the provisions of this regulation.
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