Commission Implementing Regulation (EU) 2021/808 of 22 March 2021 on the performa... (32021R0808)
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
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