INHALT

Commission 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 (Text with EEA relevance)

COMMISSION 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
(Text with EEA relevance)
Article 1
Subject matter and scope
Article 2
Definitions
Article 3
Methods of analysis
Article 4
Quality control
Article 5
Interpretation of results
Article 6
Methods for sampling
Article 7
Repeals and transitional measures
Article 8
Entry into force
ANNEX I
CHAPTER 1
PERFORMANCE CRITERIA AND OTHER REQUIREMENTS FOR ANALYTICAL METHODS
1.1.
Requirements of screening methods
1.1.1.
Categories of suitable screening methods
1.1.2.
Requirements for biological, biochemical or physico-chemical screening
methods
1.2.
Requirements of confirmatory methods
1.2.1.
General requirements for confirmatory methods
1.2.2.
General performance criteria for confirmatory methods
1.2.2.1. Trueness by recovery
1.2.2.2. Precision
1.2.3.
Requirements for chromatographic separation
1.2.4.
Specific performance criteria for mass spectrometry
1.2.4.1. Mass spectrometric detection
1.2.4.2. Identification
1.2.5.
Specific performance criteria for the determination of an analyte using liquid chromatography with detection techniques other than mass spectrometry
1.2.5.1. Performance criteria for full-scan diode array spectrophotometry
1.2.5.2. Performance criteria for fluorescence detection spectrophotometry
CHAPTER 2
VALIDATION
2.1.
Performance characteristics to be determined for analytical methods
2.2.
Trueness, repeatability and within-laboratory reproducibility
2.2.1.
Conventional validation
2.2.1.1. Trueness on the basis of a certified reference material
2.2.1.2. Trueness on basis of fortified samples
2.2.1.3. Repeatability
2.2.1.4. Within-laboratory reproducibility
2.2.2.
Validation according to alternative models
2.2.3.
Other validation approaches
2.3.
Selectivity/Specificity
2.4.
Ruggedness
2.5.
Stability
2.5.1.
Determination of the stability of the analyte in solution
2.5.2.
Determination of the stability of analyte(s) in matrix
2.6.
Decision limit for confirmation (CCα)
2.7.
Detection capability for screening (CCβ)
2.8.
Calibration curves
2.9.
Absolute recovery
2.10.
Relative matrix effects
CHAPTER 3
QUALITY CONTROL DURING ROUTINE ANALYSIS – ONGOING METHOD PERFORMANCE VERIFICATION
CHAPTER 4
EXTENSION OF THE VALIDATED SCOPE OF A PREVIOUSLY VALIDATED METHOD
4.1.
Extensions of methods as regards to the range of concentrations
4.2.
Extensions of methods as regards to additional substances
4.3.
Extensions of methods as regards to matrices/species
ANNEX II
SAMPLING PROCEDURES AND OFFICIAL SAMPLE TREATMENT
1.
Sample quantity
2.
Division into sub-samples
3.
Traceability
4.
Sample containers
5.
Sampling report
6.
Sampling report for the laboratory
7.
Transport and storage