Regulatory Update: Indonesia Publishes Regulation on Ethylene Glycol (EG) and Diethylene Glycol (DEG) Contaminants in Food Additives

The National Agency of Drug and Food Control (BPOM) in Indonesia has issued a regulatory letter concerning the presence of Ethylene Glycol (EG) and Diethylene Glycol (DEG) contaminants in certain food additives, namely Sorbitol syrup, Glycerol, and Propylene Glycol. The letter specifies that the maximum allowable limit for EG and DEG is 0.10% for each additive.

Additionally, the Indonesia Ministry of Health had previously established a limit for EG and DEG combined in Polyethylene Glycols, as outlined in the Indonesia Food Codex (KMI), with a maximum limit of 0.25%.

Since November 2022, the issue of Ethylene Glycol (EG) and Diethylene Glycol (DEG) contaminants has garnered widespread attention from pharmaceutical companies, food manufacturers, and the general public in Indonesia. These contaminants have been detected primarily in cough and fever syrup medicines and have been linked to cases of acute kidney disease in infants and children. According to reports, seven out of the 11 patients hospitalized with acute kidney disease were found to have been exposed to EG and DEG.

Any food manufacturer or importer who wishes to register or import a product containing the aforementioned food additives must provide several documents, including a Certificate of Analysis (COA) for Ethylene Glycol (EG) and Diethylene Glycol (DEG) from an accredited laboratory, a statement letter indicating the specific batch of food additive used in the product, and the specification for the food additives.

References

Indonesia National Agency of Drug and Food Control (BPOM). PW.04.08.1.5.11.22.10 year 2022. Ethylene Glycol and Diethylene Glycol Regulation on Food Additives (Sorbitol Syrup, Glycerol, and Propylene Glycol) for Registration and Importation Purpose.

Indonesia Food Codex (KMI). Indonesia Ministry of Health. Polyethylene Glycols Requirements.

PT Asuransi Reliance Indonesia. (2022). Cemaran EG dan DEG di Obat Sirup Pemicu Gagal Ginjal Akut? Retrieved from https://asuransireliance.com/health/artikel/cemaran-eg-dan-deg-di-obat-sirup-pemicu-gagal-ginjal-akut/

Cookie	Duration	Description
cookielawinfo-checbox-analytics	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checbox-functional	11 months	The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checbox-others	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-necessary	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy	11 months	The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.