On June 11, 2025, Thailand FDA issued a notification, which establishes strict contamination limits for ethylene glycol (EG) and diethylene glycol (DEG) in 12 high-risk food additives, and enhance import controls of involved products. The notification will take effect 90 days after its publication in the Royal Gazette, i.e. September 21,2025, to protect consumer safety.
Background
Concerns about EG and DEG contamination in syrup products have escalated since 2022, following multiple international reports of excessive levels of these harmful chemicals.
For instance, in October 2022, Indonesia reported syrup products with EG and DEG levels exceeding permitted limits. This contamination tragically led to acute kidney failure in at least 100 children, most under the age of five. In response, the Indonesian government moved swiftly, issuing an announcement in December 2022 that set specific limits for EG and DEG in three food additives.
In Thailand, the Thai FDA collect samples of children's cough syrup in June 2024. Testing revealed that the sorbitol in these samples—a common pharmaceutical solvent and flavoring agent—contained EG levels above the permissible standards.
Contamination Limits
Contamination Limits of Ethylene Glycol and Diethylene Glycol in 12 Food Additives
No. | Food Additive | Contamination Limit (%) | |
Ethylene Glycol | Diethylene Glycol | ||
1 | Sorbitol (INS 420(i)) | No more than 0.10 | No more than 0.10 |
2 | Sorbitol Syrup (INS 420(ii)) | No more than 0.10 | No more than 0.10 |
3 | Glycerol (INS 422) | No more than 0.10 | No more than 0.10 |
4 | Propylene Glycol (INS 1520) | No more than 0.10 | No more than 0.10 |
5 | Maltitol (INS 965(i)) | No more than 0.10 | No more than 0.10 |
6 | Maltitol Syrup (INS 965(ii)) | No more than 0.10 | No more than 0.10 |
7 | Polyglycitol Syrup (INS 964) | No more than 0.10 | No more than 0.10 |
Polysorbates | |||
8 | Polyoxyethylene (20) Sorbitan Monolaurate (INS 432) | No more than 0.25 (single or combined) | |
9 | Polyoxyethylene (20) Sorbitan Monooleate (INS 433) | No more than 0.25 (single or combined) | |
10 | Polyoxyethylene (20) Sorbitan Monopalmitate (INS 434) | No more than 0.25 (single or combined) | |
11 | Polyoxyethylene (20) Sorbitan Monostearate (INS 435) | No more than 0.25 (single or combined) | |
12 | Polyoxyethylene (20) Sorbitan Tristearate (INS 436) | No more than 0.25 (single or combined) | |
Import Controls
To prevent contaminated products from entering the market, the Thai FDA will implement rigorous import controls for the 12 specified food additives. Importers will be required to submit one of the following documents:
a) An analysis report detailing EG and DEG content, issued by a state agency laboratory or an ISO/IEC 17025 accredited laboratory.
b) A Certificate of Analysis (COA) issued by the responsible government authority in the country of origin or an ISO/IEC 17025 accredited laboratory.
These requirements also apply when these substances are imported for use as raw materials in food production. Crucially, if an importer fails to provide the necessary analysis report or COA, inspecting officers are authorized to seize the food additive for verification and testing.
Penalties for Non-Compliance
Manufacturers, importers for sale, and sellers of the 12 specified food additives found to contain EG and DEG levels that violate the new regulations will face significant penalties:
Below-standard food: Products will be classified under Section 25(3) of the Food Act B.E. 2522 (1979), carrying a maximum fine of 50,000 Baht.
Impure food: More severe violations fall under Section 25(1) of the Food Act B.E. 2522 (1979), which can result in imprisonment for up to 2 years, a fine of up to 20,000 Baht, or both.
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