New Mycotoxin EU Regulations: Key Changes and Updates

The EU has introduced several new regulations related to mycotoxins over the past year. These updates aim to simplify existing regulations, update thresholds for certain mycotoxins and commodities, bring changes to the sampling process, and introduce a new requirement for mycotoxin testing.

EU Mycotoxin Regulations (2023-2024): In brief

Simplification and Consolidation: Regulation (EU) 2023/915 consolidates previous mycotoxin regulations, repealing Regulation (EC) No 1881/2006.
Updated Thresholds: New thresholds for Deoxynivalenol (DON), T-2, and HT-2 toxins in food have been established under Regulations (EU) 2024/1022 and 2024/1038.
Sampling and Analysis: Regulation (EU) 2023/2782 updates sampling and analysis methods for mycotoxins, introducing a new requirement for the limit of quantification (LOQ) in testing.
Regulations related to animal feed: No new changes in mycotoxin limits for animal feed, but existing recommendations remain in place.

Published on:
14 June 2024

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The new Commission Regulation (EU) 2023/915 of April 2023 laying down maximum levels for certain contaminants in food repealed the Regulation (EC) No 1881/2006 which has already been updated several times. Regulation 2023/915 simplifies the complexity of mycotoxin regulations by summarizing and updating all mycotoxin maximum levels for food matrices.

However, the regulated matrices and thresholds of Deoxynivalenol have already been updated. Commission Regulation (EU) 2024/1022 of 8 April 2024 amending Regulation (EU) 2023/7915 regarding maximum levels of deoxynivalenol in food applies from 1 July 2024. Maximum levels for the sum of T-2 and HT-2 Toxin have been adapted as well. Commission Regulation (EU) 2024/1038 of 9 April 2024 adds thresholds for these two toxins.

No recent adaptations have been made to the regulatory limits of mycotoxins in feed. The following recommendations remain in force:

DIRECTIVE 2002/32/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 May 2002 on undesirable substances in animal feed
COMMISSION RECOMMENDATION of 17 August 2006 on the presence of deoxynivalenol, zearalenone, ochratoxin A, T-2 and HT-2 and fumonisins in products intended for animal feeding
COMMISSION RECOMMENDATION of 4 November 2013 amending Recommendation 2006/576/EC regarding T-2 and HT-2 toxin in compound feed for cats
COMMISSION RECOMMENDATION (EU) 2016/1319 of 29 July 2016 amending Recommendation 2006/576/EC as regards deoxynivalenol, zearalenone and ochratoxin A in pet food

The fourth regulation published, Commission Implementing Regulation (EU) 2023/2782 does not concern any regulated commodities or thresholds but lays down methods of sampling and analysis for the control of the levels of mycotoxins in food and repeals Regulation (EC) No 401/2006. This new regulation updates the sampling process including sample calculation. While no major changes have been made, more detailed instructions concerning commodity, product/lot weight, sample weight, sample number etc. are provided.

However, the updated regulation includes a completely new requirement - a LOQ (limit of quantification) requirement for mycotoxin testing. The regulation differentiates between two analysis methods: screening methods and confirmatory methods.

Screening methods

Analysis methods that are conducted on-site, such as ELISA or LFD, are considered screening methods. The LOQ corresponds to the maximum level of the respective mycotoxin, also referred to as Screening Target concentration (STC).

Example: Zearalenone	Maximum Level [ppb]	LOQ [ppb]
Unprocessed maize grains	350	350
Maize flour (not placed on the market for the final customer)	300	300

Confirmatory Methods

Analysis methods performed in laboratory settings, such as LC-MS/MS and HPLC, have a stricter LOQ requirement. The LOQ must not exceed 0.5 * maximum level (Max LOQ), although it is preferred that the LOQ does not exceed 0.2 * maximum level (Pref. LOQ) of the respective mycotoxin.

Example: Zearalenone	Maximum Level [ppb]	Max LOQ [ppb]	Pref. LOQ [ppb]
Unprocessed maize grains	350	175	70
Maize flour (not placed on the market for the final customer)	300	150	60

There are also exceptions to the LOQ calculation for confirmatory methods. For example, in Aflatoxin (sum of B1, B2, G1, G2) analysis the LOQ must be ≤ 1 ppb for all matrices (for baby food and food for medical purposes ≤ 0.1 ppb).

Romer Labs AgraStrip® Pro WATEX® and AgraQuant® test kits are screening methods, and therefore the LOQ must be below the maximum level. All AgraStrip® Pro WATEX® and AgraQuant® test kits are compliant with the new EU regulation.