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Changes to the Maximum Levels for Ergot Alkaloids, Ergot Sclerotia, and Tropane Alkaloids
21.7.2021

Changes to the Maximum Levels for Ergot Alkaloids, Ergot Sclerotia, and Tropane Alkaloids

At their conference at the beginning of the year, the Standing Committee passed draft regulations for changing the maximum levels for ergot alkaloids, ergot sclerotia, and tropane alkaloids. The amendments will be adopted in the EU Contaminant Regulation (EC) No. 1881/2006.

Ergot sclerotia refers to the fungal structure of the genus Claviceps, which occurs on the ears of cereal or grass instead of the kernels and seeds, and is visible as discolored sclerotia. They contain various classes of alkaloids. The most important alkaloids are ergometrine, ergosine, ergocryptine, ergocornine, as well as their epimers. In the year 2012, the European Food Safety Authority (EFSA) determined a toxicological group value for the acute reference dose (ARfD) of 1 µg/kg bodyweight and a tolerable daily intake (TDI) of 0.6 µg/kg) bodyweight. Scientific findings now indicate, however, that certain population groups could be exposed to levels are that approach the group values determined. For this reason, it was considered necessary to reduce the previous maximum levels. In detail that means that the maximum levels for ergot sclerotia in unprocessed cereals (excluding corn and rice) will be reduced to 0.2 g/kg as of January 1st, 2022. In rye, the maximum level will remain 0.5 g/kg until June 30th, 2024, then it will be lowered to 0.2 g/kg as well. For other product groups such as milled cereal products, cereal grain seeds that are intended for consumers, wheat gluten, and processed cereal-based foods, maximum levels for ergot alkaloids will be introduced generally and then further reduced by July 1st, 2024.

Since rye is a type of cereal that is at higher risk of contamination from ergot sclerotia, it is more difficult to achieve consistently low levels of ergot alkaloids. In order to give the economic sector time to react to the new maximum levels, the levels that are currently in effect will not be reduced until July 1st, 2024. With stricter adherence to good agricultural practices, and the use of improved sorting and cleaning processes, however, it should be possible to adhere to the specifications in the future.

There are transitional regulations for food products that do not adhere to the new maximum levels. They may remain on the market or be used as long as they have been brought onto the market legally before January 1st, 2022.

New maximum levels are being set for the tropane alkaloids atropine and scopolamine in corn (maize) and corn products. Previously maximum levels had been set for those tropane alkaloids in processed cereal-based foods and baby foods made from millet, sorghum, and buckwheat. If contamination is found, to a certain extent there is the possibility to remove the seeds containing tropane alkaloids in certain types of grains by sorting and cleaning them. However, for the types of grains listed above, this is not so simple. The new maximum levels are valid when the regulation enters into force. Processed cereal-based foods and baby foods that contain corn or corn products that have legally been brought onto the market before the regulation enters into force may continue to be used even if they exceed the new maximum levels.

Furthermore, the draft regulation also contains maximum levels for certain cereals and pseudo-cereals (millet, sorghum, buckwheat, and corn) and certain products based on them (milled products, cereal grain seeds that are intended for consumers, corn for filling) as well as herbal teas for the first time. For the herbal teas, products containing aniseed are differentiated from products without aniseed, which can be explained by the fact that aniseeds sometimes can be significantly contaminated with plant parts containing tropane alkaloids. Nevertheless, no specific maximum levels were set for herbal teas with fennel seeds, which can also be contaminated with plant parts containing tropane alkaloids. Nor are maximum levels planned for herbs or spices, which is why the legal assessment of these products may continue to be carried out solely based on a toxicological risk assessment. The new maximum levels are valid as of September 1st, 2022. Products that were legally placed on the market before this date but exceed the new maximum levels may continue to be sold and used.

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