Commission Implementing Regulation (EU) 2024/2052 of 30 July 2024 amending Implementing Regulation (EU) 2021/808 as regards its scope and certain performance criteria of analytical methods for residues of pharmacologically active substances used in food-producing animals
Commission Implementing Regulation (EU) 2024/2052of 30 July 2024amending Implementing Regulation (EU) 2021/808 as regards its scope and certain performance criteria of analytical methods for residues of pharmacologically active substances used in food-producing animals(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation)OJ L 95, 7.4.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/625/oj., and in particular Article 34(6) thereof,Whereas:(1)Commission Implementing Regulation (EU) 2021/808Commission Implementing Regulation (EU) 2021/808 of 22 March 2021 on the performance of analytical methods for residues of pharmacologically active substances used in food-producing animals and on the interpretation of results as well as on the methods to be used for sampling and repealing Decisions 2002/657/EC and 98/179/EC (OJ L 180, 21.5.2021, p. 84, ELI: http://data.europa.eu/eli/reg_impl/2021/808/oj). 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) 2022/1646Commission Implementing Regulation (EU) 2022/1646 of 23 September 2022 on uniform practical arrangements for the performance of official controls as regards the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof, on specific content of multi-annual national control plans and specific arrangements for their preparation (OJ L 248, 26.9.2022, p. 32, ELI: http://data.europa.eu/eli/reg_impl/2022/1646/oj)., 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) 2024/1229Commission Delegated Regulation (EU) 2024/1229 of 20 February 2024 supplementing Regulation (EU) 2019/4 of the European Parliament and of the Council by establishing specific maximum levels of cross-contamination of antimicrobial active substances in non-target feed and methods of analysis for these substances in feed (OJ L, 2024/1229, 30.4.2024, ELI: http://data.europa.eu/eli/reg_del/2024/1229/oj).. 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,HAS ADOPTED THIS REGULATION: