Recent Developments in Community Residue Control Legislation

Transcription

1 Recent Developments in Community Residue Control Legislation Gerhard Rimkus, DG SANCO, Unit E3 CRL workshop Bilthoven, 15 October

2 Outline Follow-up of the Reflection paper Dir 96/22/EC Dir 96/23/EC Reg No 2377/90 CRL working paper (state-of-the-art analytical methods for the NRCPs) Validation of screening methods for residues of pharmacologically active substances Sum MRLs when is a sample with several residues non-compliant? (Discussion paper) CRL workshop Bilthoven, 15 October

3 Reflection Paper 2377/90 96/22/EC 96/23/EC Regulation on residues CRL workshop Bilthoven, 15 October

4 Reflection Paper 2377/90 96/22/EC 96/23/EC New Regulation on MRLs Draft proposal New Regulation on control of residues Draft proposal Dir 96/22/EC amendment Draft proposal CRL workshop Bilthoven, 15 October

5 Replacement of Reg No 2377/90 by a new Regulation Draft proposal COM(2007) 194 final Drafted by DG Enterprise (chef de file) Draft proposal in Council and Parliament since summer 2007 (first reading) Published in 2009? In Force in 2010? Several new elements CRL workshop Bilthoven, 15 October

6 Replacement of Reg No 2377/90 by a new Regulation new elements (1) Definition food-producing animals (Art 2) Extrapolation to other foodstuff or species (Art 5) Application for MRLs by Commission or MS (Art 9) Direct adoption of Codex Alimentarius MRLs (if the Community position was favourable) (Art 13(3)) Merging Annexes I to IV to one Annex CRL workshop Bilthoven, 15 October

7 Replacement of Reg No 2377/90 by a new Regulation new elements (2) Reference points for action (RPAs) for substances without MRL (Art 17-19) Procedure for the establishment of RPAs is laid down 2 steps 1. performance of the analytical method, involvement of CRLs 2. risk assessment by EFSA (EMEA?) CRL workshop Bilthoven, 15 October

8 Replacement of CD 96/23/EC by a Regulation A preliminary draft presented to the national experts of the residue working group in October 2006 Discussion of the draft with the residue group in the FVO in December 2006 Some details presented at CRL workshop in Berlin in April 2007 Due to the shortage of human resources only little work on the draft in 2007, resumption probably in 2008 CRL workshop Bilthoven, 15 October

9 Amendment of CD 96/22/EC (I) Two objectives: 1. to implement Article 11a 17ß-oestradiol is a complete carcinogen Report from the University of Liverpool indicated that alternatives are available From Annex III to Annex II A (=completely prohibited, together with stilbenes and thyrostatics) Articles 5a deleted and 11a replaced/shortened CRL workshop Bilthoven, 15 October

10 Amendment of CD 96/22/EC (II) 2. to remove pet animals from the scope Currently Article 2a (Annex II A substances) refers to animals of all species Treatment of hyperthyroidism in cats and dogs (animal welfare aspects) Former assumption: pet products can be misused for growth promotion in food producing animals proposal to change scope in Article 2 (Annex II substances prohibited for food-producing animals) CRL workshop Bilthoven, 15 October

11 CRL working paper (state-of-the-art analytical methods for the NRCP) - Objectives To advice the NRLs and MS in order to improve the NRCPs To harmonise the performance of the MS laboratories, technical recommendation, Recommended concentrations MRPLs! For substances without MRLs (group A substances, non-authorised substances e.g. MG, antimicrobials in honey etc.) Recommendation for matrices of choice, marker residues and concentrations CRL workshop Bilthoven, 15 October

12 CRL working paper (state-of-the-art analytical methods for the NRCP) - History Draft proposal presented to the national experts of the residue working group in June and October 2006 Comments from MS and NRLs CRLs revised the document and answered to MS/NRLs comments Consolidated version discussed at the meeting of the residue working group in May 2007 Status quo: still open questions, to consult the CRLs again CRL workshop Bilthoven, 15 October

13 CRL working paper (state-of-the-art analytical methods for the NRCP) - Future To finalise the document in November 2007 final document as internal document to the national coordinators and CRLs/NRLs also foreseen as information in the Residue Application No publication on the SANCO website! CRL working paper MRPLs RPAs (CD 2002/657/EC) ( new 2377/90 ) CRL workshop Bilthoven, 15 October

14 Validation of screening methods for residues of pharm. active substances - Status quo (I) MS use a variety of antimicrobial growth inhibition tests which have not been validated using either incurred or spiked tissues If validation available, mostly only using aqueous standard solutions Tests regarded as being standardised Tests often performed in microbiological units (not under the scope of CD 2002/657/EC) Scope of analytes and sensitivity in different matrices not known CRL workshop Bilthoven, 15 October

15 Validation of screening methods for residues of pharm. active substances - Status quo (II) Commercially available kits (ELISA, CHARM, Delvo many laboratories have not carried out any in-house validation in general manufacturers data accepted tests often performed in microbiological units (not under the scope of CD 2002/657/EC) Validation needed for screening tests Validation should be performed in the framework of CD 2002/657/EC Agreed validation guidelines could be useful CRL workshop Bilthoven, 15 October

16 Validation of screening methods for residues of pharm. active substances Initial validation a method newly developed or strongly modified in comparison to existing methods all matrices, species and relevant compounds have to be validated Laboratories concerned: developers (e.g. CRLs, NRLs) of methods kit manufacturers CRL workshop Bilthoven, 15 October

17 Validation of screening methods for residues of pharm. active substances Transfer validation Initially validated method, transferred without any changes of the procedure (sample preparation, analysis) or commercial kits only selected matrices, species and analyte combinations have to be validated (fewer number of samples than initial validation) Laboratories concerned: field control laboratories when the method is transferred from NRLs NRLs when the method is transferred from CRLs All laboratories when using a commercial kit for official control CRL workshop Bilthoven, 15 October

18 Validation of screening methods for residues of pharm. active substances Matrices/substances Choice of matrices: One or several matrices depending on the official samples Inhibition tests: Definition of simulated tissue Choice of substances: All relevant analytes if possible Scope of the method and demands of the control List of representative antimicrobials (inhibition tests) cross-reactivities (ELISA test) CRL workshop Bilthoven, 15 October

19 Validation of screening methods for residues of pharm. active substances Guideline History (I) Starting point: workshop in CRL Fougères in June 2005 Draft guidelines, together with several NRLs and CRLs Draft version 3 discussed in May 2007 (COMM and 3 CRLs) Draft version 5 from CRL Berlin in August 2007 Draft version 5 from CRL Fougères in September 2007 CRL workshop Bilthoven, 15 October

20 Validation of screening methods for residues of pharm. active substances Guideline History (II) Meeting in Brussels 4 October 2007 (COMM and 3 CRLs) Draft version 5 very complex and comprehensive agreed to focus in the first step on transfer of methods Focusing on biological tests (inhibition tests) and biochemical tests (ELISA) Additional new elements: QC and validation report Publication on SANCO website foreseen CRL workshop Bilthoven, 15 October

21 Sum MRLs when is a sample with several residues non-compliant? (Discussion paper)-i Sum MRLs: e.g. sulfonamides, parent substances + metabolites How to calculate CC alpha when several substances are found in one control sample? 3 proposals presented and discussed at CRL workshop in Berlin in April 2007 Preferred approach: adding the individual uncertainties (RSDs) - determined at the MRL - by means of error propagation law and weighing the uncertainties by the detected concentrations Sum > CC alpha control sample is non-compliant CRL workshop Bilthoven, 15 October

22 Sum MRLs when is a sample with several residues non-compliant? (Discussion paper)-ii Example: sum MRL = 100 ppb substance 1: 15 ppb; w 1 = 0.13 (RSD MRL =20 %; CC alpha =133ppb) substance 2: 30 ppb; w 2 = 0.26 (RSD MRL =12 %; CC alpha =120 ppb) substance 3: 70 ppb; w 3 = 0.61 (RSD MRL = 8 %; CC alpha =113 ppb) Sum = 115 ppb Square root (w 1 * RSD 2 MRLsub1 + w 2 *RSD 2 MRLsub2 + w 3 *RSD 2 MRLsub3 ) Square root (0.13* * *8 2 )=11.33% ppb CC alpha = 100 ppb *11.33 ppb = 119 ppb Sum (115 ppb) < CC alpha (119 ppb) sample is compliant! CRL workshop Bilthoven, 15 October

23 Thank you for your attention! CRL workshop Bilthoven, 15 October