Commission Regulation (EU) 2017/644Show full title

1. Introductory Text

2. Article 1. For the purposes of this Regulation, the definitions and abbreviations...

3. Article 2. Sampling for the official control of the levels of dioxins,...

4. Article 3. Sample preparation and analyses for the control of the levels...

5. Article 4. Analyses for the control of the levels of non-dioxin-like PCBs...

6. Article 5. Regulation (EU) No 589/2014 is repealed. References to the repealed...

7. Article 6. This Regulation shall enter into force on the twentieth day...

8. Signature

9. 1. ANNEX I

      DEFINITIONS AND ABBREVIATIONS

      1. I. DEFINITIONS

      2. II. ABBREVIATIONS USED

   2. ANNEX II

      METHODS OF SAMPLING FOR OFFICIAL CONTROL OF LEVELS OF DIOXINS (PCDD/PCDF), DIOXIN-LIKE PCBs AND NON-DIOXIN-LIKE PCBs IN CERTAIN FOODSTUFFS

      1. I. SCOPE

      2. II. GENERAL PROVISIONS

         1. 1. Personnel

         2. 2. Material to be sampled

         3. 3. Precautions to be taken

         4. 4. Incremental samples

         5. 5. Preparation of the aggregate sample

         6. 6. Replicate samples

         7. 7. Packaging and transmission of samples

         8. 8. Sealing and labelling of samples

      3. III. SAMPLING PLAN

         1. 1. Division of lots into sublots

         2. 2. Number of incremental samples

         3. 3. Specific provisions for the sampling of lots containing whole fishes...

         4. 4. Sampling of lots of fish containing whole fishes of different...

         5. 5. Sampling at retail stage

      4. IV. COMPLIANCE OF THE LOT WITH SPECIFICATION

         1. 1. As regards non-dioxin-like PCBs

         2. 2. As regards dioxins (PCDD/Fs) and dioxin-like PCBs

      5. V. EXCEEDANCE OF ACTION LEVELS

   3. ANNEX III

      SAMPLE PREPARATION AND REQUIREMENTS FOR METHODS OF ANALYSIS USED IN CONTROL OF THE LEVELS OF DIOXINS (PCDD/FS) AND DIOXIN-LIKE PCBs IN CERTAIN FOODSTUFFS

      1. 1. FIELD OF APPLICATION

         1. (a) Screening methods

         2. (b) Confirmatory methods

      2. 2. BACKGROUND

      3. 3. QUALITY ASSURANCE REQUIREMENTS

      4. 4. REQUIREMENTS FOR LABORATORIES

      5. 5. BASIC REQUIREMENTS TO BE MET BY ANALYTICAL PROCEDURE FOR DIOXINS...

         1. 5.1. Low working range and limits of quantification

         2. 5.2. High selectivity (specificity)

         3. 5.3. High accuracy (trueness and precision, bioassay apparent recovery)

         4. 5.4. Validation in the range of maximum level and general quality...

         5. 5.5. Limit of quantification

         6. 5.6. Analytical criteria

         7. 5.7. Specific requirements for screening methods

      6. 6. SPECIFIC REQUIREMENTS FOR GC-MS METHODS TO BE COMPLIED WITH FOR...

         1. 6.1. Acceptable differences between upperbound and lowerbound WHO-TEQ levels

         2. 6.2. Control of recoveries

         3. 6.3. Removal of interfering substances

         4. 6.4. Calibration with standard curve

         5. 6.5. Specific criteria for confirmatory methods

      7. 7. SPECIFIC REQUIREMENTS FOR BIOANALYTICAL METHODS

         1. 7.1. Evaluation of the test response

            1. 7.1.1. General requirements

            2. 7.1.2. Calibration

               1. 7.1.2.1. Calibration with standard curve

               2. 7.1.2.2. Calibration with reference samples

            3. 7.1.3. Separate determination of PCDD/Fs and dioxin-like PCBs

            4. 7.1.4. Bioassay apparent recoveries

            5. 7.1.5. Control of recoveries for clean-up

            6. 7.1.6. Reporting Limit

         2. 7.2. Use of reference samples

         3. 7.3. Determination of cut-off values

            1. 7.3.1. Use of the lower band of the 95 % prediction...

            2. 7.3.2. Calculation from bioanalytical results (corrected for blank and recovery) of...

            3. 7.3.3. Calculation as mean value of bioanalytical results (in BEQ, corrected...

               1. Figure 1

            4. 7.3.4. Restrictions to cut-off values

         4. 7.4. Performance characteristics

      8. 8. REPORTING OF THE RESULT

         1. Confirmatory methods

         2. Bioanalytical screening methods

         3. Physico-chemical screening methods

      9. Appendix

         WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (WHO) 0151 International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005

   4. ANNEX IV

      SAMPLE PREPARATION AND REQUIREMENTS FOR METHODS OF ANALYSIS USED IN CONTROL OF THE LEVELS OF NON-DIOXIN-LIKE PCBS IN CERTAIN FOODSTUFFS

      1. The requirements set out in this Annex shall be applied...

      2. The provisions on sample preparation provided for in point 3...

      3. 1. Applicable detection methods

      4. 2. Identification and confirmation of analytes of interest:

      5. 3. Demonstration of performance of method:

      6. 4. Limit of quantification:

      7. 5. Quality control:

      8. 6. Control of recoveries:

      9. 7. Requirements for laboratories

      10. 8. Performance characteristics: Criteria for the sum of non-dioxin-like PCBs at...

      11. 9. Reporting of results

   5. ANNEX V

      1. For the purposes of this Annex the following definitions apply—...