A) Establishing Routine Methods to Meet Codex Maximum Residue Limit Requirements
B) Methods of Analysis and Sampling for Residues of Veterinary Drugs in Foods
57. The Committee referred to the decision made at its Ninth Session (1995) mat if no method of analysis acceptable to the Committee was available to monitor an MRL, that the MRL should not be advanced beyond Step 7[14]. At that time the Committee had noted the problems of inter-laboratory validation and the difficulty of validating methods in its field of competence by at least three analysts in three laboratories. The Committee had requested that a paper be prepared on the issue and include criteria for the validation of an analytical method.
58. The need for reliable methods for use in monitoring compliance with MRLs was stressed by the Committee, and there was general agreement that the identification of appropriate methodology was an integral part of decision-making in a risk analysis framework. However, the practical problems of applying inappropriate or unrealistic validation criteria to the identification of methods were also recognized. The Committee noted that at a national or regional level these problems seemed not to exist and more pragmatic approaches were in use; for example, methods validated using intra-laboratory criteria combined with quality systems-based laboratory accreditation. It was further noted that performance-based methods were available for many of the MRLs retained at Step 7, the only constraint being that these methods had not been validated in inter-laboratory collaborative trials. It was noted that specific problems could arise, such as reliance on costly methods which were beyond the accessibility of many developing countries.
59. Noting that its Terms of Reference required the Committee "to determine criteria for analytical methods used for the control of veterinary drug residues in foods"[15] but did not extend to the consideration of methods of analysis per se, the Committee agreed that all MRLs currently retained at Step 7 should be considered for advancement to Step 8 on this occasion. It reiterated the need for monitoring methods to be available in order to meet normal residue control practices, and stated that in the future, methods conforming to established performance criteria should normally be available before advancing MRLs to step 8.
60. The Committee was informed that the Executive Committee had approved a proposal of the Committee on Methods of Analysis and Sampling (CCMAS) to review the criteria for evaluating acceptable methods of analysis for Codex purposes as new work[16]. However, it was noted that many of the issues raised in the present context were of potential concern in other areas of the Commission's work, including pesticide residues, contaminants and microbiological analysis. The Committee proposed that the Commission request FAO, together with WHO if it so wished, to give consideration to convening an Expert Consultation on the question of methods validation for food control purposes.
61. The Committee complimented the Delegation of Australia for the comprehensive paper on this issue, and noted that its content had important implications for other Codex committees and recommended that the paper be referred to CCMAS and brought to the attention of the Codex Committees on Pesticide Residues, Food Additives and Contaminants and Food Hygiene. It requested the Delegation to revise the document in the light of the present discussion and invited Delegations to forward comments directly to Australia with a view to circulating the paper for comments in advance of the Committee's next Session.
62. The Committee accepted the ad hoc Working Group's recommendations concerning the status of analytical methods. These recommendations were incorporated into the Committee's consideration of individual MRLs under Agenda Items 7 and 8. The Working Group's recommendations regarding amendments to methods of analysis for previously adopted MRLs are attached to this report at Appendix VIII.
63. The Committee thanked the ad hoc Working Group for its in-depth consideration of the matters referred to it over the years, and recognized the practical usefulness of identifying methods for routine control purposes. It agreed to re-instate the Working Group for its next Session in order to continue work and to review alternative proposals for performance-based criteria for the evaluation of routine control methods.
