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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in foodnote, and in particular Article 2(3) thereof,Whereas:
(1)Commission Regulation (EU) 2023/915note sets maximum levels for certain contaminants, including deoxynivalenol (DON) in food.
(2)In 2017, the European Food Safety Authority (‘the Authority’) adopted a scientific opinion on the risks to human and animal health related to the presence of deoxynivalenol and its acetylated and modified forms in food and feednote. The Authority concluded in that opinion that the tolerable daily intake (TDI) of 1 μg/kg body weight (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.
(3)In light of the Authority’s opinion, the Commission has 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 in particular DON-3-glucoside are not yet analysed on a routine basis, there is insufficient information at this time to set such maximum levels until the method of analysis for the routine analysis of the acetylated and modified forms of DON is further developed and the presence of the sum of DON and its acetylated and modified forms is monitored. In the meantime, in order to ensure a high level of public health protection, it is 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 minimise contamination and thereby taking into account recent occurrence data.
(4)In order to ensure that good agricultural practices are applied to minimise 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.
(5)Regulation (EU) 2023/915 should therefore be amended accordingly.
(6)It is appropriate to provide for a transitional period for food lawfully placed on the market before the date of application of this Regulation taking into account that certain foods covered by this Regulation have a long shelf life.
(7)To enable economic operators to prepare for the new rules introduced by this Regulation, it is appropriate to provide for a reasonable time until the new maximum levels apply.
(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1#
Annex I to Regulation (EU) 2023/915 is amended in accordance with the Annex to this Regulation.
Article 2#
Food listed in the Annex, lawfully placed on the market before 1 July 2024, may remain on the market until their date of minimum durability or use-by date.
Article 3#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 1 July 2024.
In Section 1 (mycotoxins) of Annex I to Regulation (EU) 2023/915, entry 1.4 (deoxynivalenol) is replaced by the following:
1.4 | Deoxynivalenol | Maximum level (μg/kg) | Remarks1.4.1 | Unprocessed cereal grains except products listed in 1.4.2 and 1.4.3 | 1000 | Except unprocessed maize grains intended to be processed by wet milling and except rice.The maximum level applies to unprocessed cereal grains placed on the market for first-stage processing (6).1.4.2 | Unprocessed durum wheat grains and unprocessed maize grains | 1500 | Except unprocessed maize grains for which it is evident e.g. through labelling or, destination, that they are intended for use in a wet milling process only (starch production).The maximum level applies to unprocessed durum wheat grains and unprocessed maize grains placed on the market for first-stage processing (6).1.4.3 | Unprocessed oat grains with inedible husk | 1750 | The maximum level applies to unprocessed oat grains with husk placed on the market for first-stage processing (6).The maximum level applies to the oat grains with the inedible husk included.1.4.4 | Cereals placed on the market for the final consumer, maize for popping and popcorn | 750 | Except rice.1.4.5 | Milling products of cereals with the exception of products listed in 1.4.6 | 600 | Except milling products of rice.1.4.6 | Milling products of maize | |1.4.6.1 | Milling products of maize placed on the market for the final consumer | 750 |1.4.6.2 | Milling products of maize not placed on the market for the final consumer | 1000 |1.4.6.3 | Pre-cooked polenta ready to eat | 250 |1.4.7 | Bakery wares, cereal snacks and breakfast cereals | 400 | Except rice products.Including small bakery wares.1.4.8 | Pasta | 600 | Pasta means pasta (dry) with a water content of approximately 12 %.1.4.9 | Baby food and processed cereal-based food for infants and young children (3) | 150 | Except rice products.The maximum level applies to the dry matter (5) of the product as placed on the market.1.4.10 | Food for special medical purposes intended for infants and young children (3) | 150 | Except rice products.The maximum level applies to the dry matter (5) of the product as placed on the market.
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