Kommisjonens gjennomføringsforordning (EU) 2024/2052 av 30. juli 2024 om endring av gjennomføringsforordning (EU) 2021/808 med hensyn til omfanget og visse ytelseskriterier for analysemetoder for rester av farmakologisk aktive stoffer brukt i matproduserende dyr
Analysemetoder for rester av farmakologisk aktive stoffer i matproduserende dyr: endringsbestemmelser
Kommisjonsforordning publisert i EU-tidende 31.7.2024
Tidligere
- Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 20.6.2024
Nærmere omtale
BAKGRUNN (fra kommisjonsforordningen)
(1) Commission Implementing Regulation (EU) 2021/808 lays down rules on the performance of analytical methods for residues of pharmacologically active substances used in food-producing animals, on the interpretation of results and on the methods to be used for sampling.
(2) Implementing Regulation (EU) 2021/808 concerns, among others, performance criteria for analytical methods in relation to residues of pharmacologically active substances in feed. It should, however, be clarified that Implementing Regulation concerns only the methods used to verify compliance with certain rules fixing regulatory levels in feed, covered by the multi-annual national control plans in the area of residues of pharmacologically active substances mentioned in Commission Implementing Regulation (EU) 2022/1646 , and does not concern the methods used to verify compliance with rules on cross-contamination of antimicrobial active substances in non-target feed, referred to in Commission Delegated Regulation (EU) 2024/1229 . The scope of Implementing Regulation (EU) 2021/808 should be amended accordingly.
(3) Since the adoption of Implementing Regulation (EU) 2021/808, several international standards have been updated. In order to ensure that the relevant references remain accurate, they should be updated accordingly.
(4) In order to ensure that performance criteria are adequately checked, it should be explicitly mentioned in Implementing Regulation (EU) 2021/808 that any deviations from the established technical criteria should be documented and analysed with traceable evidence kept. Therefore, this requirement should be added to the general requirements of the analytical methods.
(5) The transition period for certain provisions laid down in Article 7 of Implementing Regulation (EU) 2021/808 has ended. Consequently, it is appropriate to amend that Article accordingly.
(6) To improve the readability of general requirements for confirmatory methods, certain parts of the relevant provisions should be included in a specific subchapter referring to the specific use of co-chromatography.
(7) Based on the experience gained during the implementation of Implementing Regulation (EU) 2021/808, the coefficient of variation under repeatability conditions in certain cases cannot fulfil the requirements laid down as regards their precision and therefore this requirement should be amended to take into account reproducibility conditions.
(8) According to the performance characteristics, screening methods can be of three different types. Although qualitative and quantitative methods are defined in Implementing Regulation (EU) 2021/808, an explanation of the semi-quantitative screening method is missing. Therefore, an explanation of this type of method should be added to the classification of analytical methods.
(9) The requirements for performing several individual experiments for every major change currently refers to ruggedness. Since also the other performance characteristics are to be checked with the major change, a reference to all the necessary performance characteristics should be mentioned and therefore the relevant provisions should be amended accordingly.
(10) For a non-allowed pharmacologically active substance, validation of a concentration of 0,5 times the reference points per action (RPA) is requested. However, sometimes it is not reasonably achievable as the concentration is too low from the analytical point of view and, therefore, the concentration of 0,5 times the RPA can be replaced by the lowest concentration between 0,5 times and 1,0 times the RPA, which is reasonably achievable. For some cases, the lowest calibrated level can be lower than 0,5 times the RPA and therefore the possibility of validation at this concentration level should be added into the relevant footnotes.
(11) To clarify the total number of replicates required for the determination of repeatability and within-laboratory reproducibility, this number should be explicitly mentioned in the relevant subcategories.
(12) Validation of the analytical methods can be performed according to alternative models using an experimental plan. Currently, there is an international standard ISO/TS 23471:2022 available and, therefore, the reference to it should be added as another possibility for calculation of the method characteristics.
(13) When determining the stability of an analyte, an isochronous approach allows an improved determination of potential analyte instabilities as well as an estimation of appropriate storage periods. Therefore, this approach should be added to the options for determination of the stability of the analyte.
(14) During the implementation of Implementing Regulation (EU) 2021/808, the procedure describing the determination of the stability of analyte in matrix resulted in different interpretations. It is therefore appropriate to further clarify that procedure, in particular in the steps of fortification of the analyte and in the use of proper terms of aliquots and portions.
(15) Currently. the calculation of the detection capability for screening (CCβ) for Method 2 for unauthorised or prohibited pharmacologically active substances includes only the cases where the chosen screening target concentration provides less than or equal to 5 % false compliant results. Therefore, a provision for the case where the percentage of false compliant results is higher than 5 should be added.
(16) For the screening methods, only the CCβ for the individual substance is reported. Therefore, the additional provision for the sum of CCβ, included in the provisions for calculation of CCβ, is redundant and should be deleted.
(17) The need to determine the absolute recovery of the method depends on the unavailability of the internal standard or on whether a matrix-fortified calibration is used or not. The current wording that the absolute recovery of the method is to be determined when no internal standard or no matrix-fortified calibration is used can be confusing, as it could be understood that both cases occur together, when only one of two conditions is sufficient to determine the absolute recovery.
(18) Regarding relative matrix effects, currently, the value of the coefficient of variation refers to a maximum numerical percentage without differentiation of the mass fractions. Since Table 2 of Annex I to Implementing Regulation (EU) 2021/808 presents various acceptable coefficients of variations depending on the different mass fractions, the acceptable coefficient of variation should refer to the values listed in that table.
(19) Implementing Regulation (EU) 2021/808 should therefore be amended accordingly.
(20) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,