The European Commission (EC) recently made changes to the maximum levels of the mycotoxin deoxynivalenol (DON) in food with Commission Regulation (EU) 2024/1022, amending Regulation (EU) 2023/915.

In 2017, the European Food Safety Authority (EFSA) adopted a scientific opinion on the risks to human and animal health related to the presence of DON and its acetylated and modified forms in food and feed­. EFSA concluded that the tolerable daily intake (TDI) of 1 microgram per kilogram of body weight (μg/kg bw) per day for DON, was to be considered as a group-TDI for the sum of DON, 3-acetyl-deoxynivalenol (3-Ac-DON), 15-acetyl-deoxynivalenol (15-Ac-DON), and deoxynivalenol-3-glucoside (DON-3-glucoside). In order to assess acute human health risk, a group acute reference dose (ARfD) of 8 μg/kg bw per eating occasion was calculated. Estimates of acute dietary exposures were below this dose and did not raise a health concern in humans. However, the estimated mean chronic dietary exposures were above the group-TDI in infants, toddlers and other children, and at high exposures also in adolescents and adults, indicating a potential health concern.

In light of EFSA’s opinion, EC considered the possibility of setting maximum levels for the sum of DON, 3-Ac-DON, 15-Ac-DON, and DON-3-glucoside. However given the limited amount of occurrence data for the sum of DON, 3-Ac-DON, 15-Ac-DON, and DON-3-glucoside, and given that 3-Ac-DON, 15-Ac-DON, and DON-3-glucoside are not yet analyzed on a routine basis, there is insufficient information to set maximum levels at present. In the meantime, in order to ensure a high level of public health protection, EC finds it appropriate to lower certain existing maximum levels for DON, following the principle that maximum levels are to be set at a level as low as reasonably achievable by applying good practices to minimize contamination, and taking into account recent occurrence data.

In order to ensure that good agricultural practices are applied to minimize the presence of DON in cereals, it is important to lay down a maximum level for unprocessed cereals. As unprocessed oats, before milling or before being used in cereal products placed on the market for the final consumer, are placed on the market with the husk, the maximum level for DON in unprocessed oat grains should apply to the unprocessed oat grains with the husk included, even if the husk is inedible. The new regulation sets forth a maximum level for DON in unprocessed cereal grains, among other foods, as follows:

  • Unprocessed cereal grains (unless otherwise specified, and except for rice and for unprocessed maize grains intended for processing by wet milling; applies to unprocessed cereal grains placed on the market for first-stage processing): 1,000 μg/kg
  • Unprocessed durum wheat grains and unprocessed maize grains (except unprocessed maize grains destined for a wet milling process; applies to unprocessed cereal grains placed on the market for first-stage processing): 1,500 μg/kg
  • Unprocessed oat grains with inedible husk (husk included; applies to unprocessed cereal grains placed on the market for first-stage processing): 1,750 μg/kg
  • Cereals placed on the market for the final consumer (except rice), maize for popping, and popcorn: 750 μg/kg
  • Milling products of cereals (unless otherwise specified, and except for rice): 600 μg/kg
  • Milling products of maize placed on the market for the final consumer: 750 μg/kg
  • Milling products of maize not placed on the market for the final consumer: 1,000 μg/kg
  • Precooked, ready-to-eat (RTE) polenta: 250 μg/kg
  • Bakery wares, cereal snacks, and breakfast cereals (including small bakery wares and except for rice products: 400 μg/kg
  • Pasta (dry with a water content of approximately 12 percent): 600 μg/kg
  • Baby food, processed cereal-based food, and medical food for babies and young children (except for rice; applies to dry matter of the product): 150 μg/kg.