Veterinary drug residues: correction of 12 language versions of Regulation 2021/808 on the decision limit CCα and the detection capability CCβ — the Polish Article 5(2) now reads “at and above which” instead of “at or above which”; the German version likewise
Commission Implementing Regulation (EU) 2025/127, published on 28 January 2025, corrects the Bulgarian, Croatian, Czech, Danish, Estonian, Spanish, Irish, German, Polish, Portuguese, Slovak and Slovenian versions of Implementing Regulation (EU) 2021/808 on the performance of analytical methods for residues of pharmacologically active substances in food-producing animals. The errors concerned the definition and calculation of CCα and the calculation of CCβ; in the Polish version only Article 5(2) was corrected.
- New wording of Article 5(2) (Polish version): it now states that the decision limit for confirmation (CCα) for authorised substances with an MRL or ML is the concentration “at and above which” it can be decided with a statistical certainty of 1 – α that the permitted limit has been exceeded — previously “at or above which”. The English version has said “at and above which” from the start; the German version had “bei oder über” and now reads “bei und über”. Unchanged: a result is non-compliant where it is equal to or above CCα (Article 5(1)), and the α error is at most 1 % for unauthorised or prohibited substances and 5 % for all others (paragraph 4).
- All corrected provisions (recitals 1–6): the definition of CCα in the second paragraph, point 14, of Article 2 — Czech, Estonian and Irish versions; Article 5(2) — Czech, Danish, Estonian, Spanish, Irish, German and Polish; point 2.6.(1)(a), second sentence, of Annex I — Bulgarian, Croatian, Czech, Irish and Portuguese; point 2.6.(2)(a)(i) — the same plus Slovenian; point 2.7.(1)(a) on CCβ for screening — Bulgarian, Croatian, Irish and Slovak; point 2.7.(2)(a) — Croatian. According to the recitals, the errors in the annex could lead to an incorrect calculation of CCα or CCβ.
- What the corrected points concern (Regulation 2021/808): Method 1 for unauthorised or prohibited substances — calibration curve according to ISO 11843-1:1997 on blank material fortified from the reference point for action (RPA) or the lowest calibrated level (LCL) in equidistant steps; CCα is the concentration at the y-intercept plus 2.33 times the standard deviation of within-laboratory reproducibility. For authorised substances with an MRL — the concentration at the MRL plus 1.64 times the standard deviation (α = 5 %), or CCα = MRL + k(one-sided, 95 %) × combined standard uncertainty.
- A deadline from the same annex relevant in 2026: Method 2 for calculating CCα for prohibited substances (three times the signal-to-noise ratio from at least 20 representative blank materials) could be used only until 1 January 2026 and only for methods validated before Regulation 2021/808 entered into force; methods validated later may use only Methods 1 or 3. The correction entered into force on the twentieth day after publication and does not affect the other language versions.