Establishment of the Maximum Limit for Deoxynivalenol (DON) in Foods. 
 
Outline of revision 
From the viewpoint of public health, the Minister of Health, Labour and 
Welfare (MHLW) is authorized to establish specifications and standards for 
food or additives to be served for the purpose of marketing by hearing the 
opinions of the Pharmaceutical Affairs and Food Sanitation Council. (Food 
Sanitation Act Article 11 Paragraph 1) 
 
Based on the conclusion of discussion conducted by the Committee on 
Standards for Food* on September 22, 2017, the MHLW has decided to 
establish a maximum limit (ML) for Deoxynivalenol (DON) in wheat at 1.0 
mg/kg. 
* The Committee of the Standards for Food is one of the advisory bodies of the Food 
Sanitation Council that is established under the Pharmaceutical Affairs and Food 
Sanitation Council. 
 
 
 Background 
Deoxynivalenol (DON) is a trichothecene mycotoxin produced in cereals 
(especially wheat, maize and barely) by mainly G. zeae, F. graminearum and 
F. culmorum.  It is known to cause acute toxicity characterized by emesis 
and disorders of the lymphoid tissue and digestive tract and chronic toxicity 
characterized by symptoms including weight loss.  
 
In May 2002 the MHLW established a provisional standard limit of 1.1 
mg/kg for wheat because a high concentration of DON (2.2 mg/kg) was 
detected in wheat distributed in the Japanese market. In July 2015 the 
Codex Alimentarius Commission set maximum levels for DON in wheat, 
maize, and barley. （CODEX STAN 193-1995） 
 
Wheat is a secondary staple food in Japan and most of wheat consumed in 
Japan is imported.  In light of past food poisoning cases associated with 
DON, Japan will establish the ML for DON in wheat to prevent a public  health risk. The ML has been derived applying the Codex ALARA principle1, 
based on the actual situation of contamination of imported wheat and 
exposure assessment for Japanese consumers. 
 
Provisional standard Maximum Limit (draft) 
1.1 mg/kg for wheat 1.0 mg/kg for wheat 
 
 
Concept of setting MLs 
 
・Codex Alimentarius Commission separately set the maximum levels for 
DON in cereals (wheat, maize, and barley) in three categories: cereal 
grains for further processing, flour, and cereal-based foods for infants and 
young children. In Japan, however, it is difficult to process wheat to 
reduce possible contamination by DON. In addition, it is not easy to 
separately regulate wheat-based foods for infants and children. 
・Exposure assessment conducted by the Ministry of Agriculture, Forestry 
and Fisheries of Japan has found that if a maximum limit (ML) of 1.0 
mg/kg is applied to wheat, the 95th percentile of the orally ingested DON 
by pre-school children would be the same level as the tolerable daily 
intake (TDI) for DON set by the Food Safety Commission of Japan, a risk 
assessment body, in the Cabinet Office. This means the application of the 
ML of 1.0 mg/kg will ensure food safety.  
・Codex Alimentarius Commission sets maximum levels as low as reasonably 
achievable based on actual contamination studies, considering so that the 
violation rate can be 2–3%. According to the study carried out by the 
MHLW, an ML of 1.0 mg/kg will result in a violation rate of about 2%.  
 
 
                                            
1 The ALARA principle: The principle that MLs should be set “As Low As Reasonably 
Achievable.” The principle is used for Codex Committee on Contaminants in Foods to set 
standards.