On February 18, 2025, Thailand Food and Drug Administration (Thai FDA) issued a draft notification, establishing maximum contamination limits of ethylene glycol (EG) and diethylene glycol (DEG) in 12 high-risk food additives. Stakeholders are invited to submit comments to Thai FDA by March 3.
Background
Diethylene glycol (DEG) and ethylene glycol (EG) are toxic chemical compounds primarily employed as industrial solvents and antifreeze agents, capable of inducing fatal poisoning even at low exposure levels, with heightened risks for children. The World Health Organization has identified contamination incidents involving these compounds in medicinal preparations such as cough syrups, where the excipient sorbitol was found adulterated with ethylene glycol. Furthermore, scientific investigations have revealed potential cross-contamination of specific food additives with both substances during manufacturing processes.
Key requirements
All specified additives must comply with both:
Existing quality standards under the Codex Advisory Specifications for Food Additives
New EG/DEG contamination limits outlined in the notification
Contamination limits
INS Number | Food Additive | Maximum EG Level | Maximum DEG Level |
420(i) | Sorbitol | ≤0.10% | ≤0.10% |
420(ii) | Sorbitol Syrup | ≤0.10% | ≤0.10% |
422 | Glycerol | ≤0.10% | ≤0.10% |
1520 | Propylene Glycol | ≤0.10% | ≤0.10% |
965(i) | Maltitol | ≤0.10% | ≤0.10% |
965(ii) | Maltitol Syrup | ≤0.10% | ≤0.10% |
964 | Polyglycitol Syrup | ≤0.10% | ≤0.10% |
432 | Polyoxyethylene (20) Sorbitan Monolaurate | ≤0.25%* | ≤0.25%* |
433 | Polyoxyethylene (20) Sorbitan Monooleate | ≤0.25%* | ≤0.25%* |
434 | Polyoxyethylene (20) Sorbitan Monopalmitate | ≤0.25%* | ≤0.25%* |
435 | Polyoxyethylene (20) Sorbitan Monostearate | ≤0.25%* | ≤0.25%* |
436 | Polyoxyethylene (20) Sorbitan Tristearate | ≤0.25%* | ≤0.25%* |
*Applies to single or combined contamination levels
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