Guidance on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non‐allowed pharmacologically active substances present in food of animal origin

摘要

EFSA was asked by the European Commission to deliver a Scientific Opinion on guidance on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non‐allowed pharmacologically active substances in food of animal origin. This guidance document presents a simple and pragmatic approach which takes into account both analytical and toxicological considerations. The aim is to define an analytical concentration for a non‐allowed pharmacologically active substance that can be determined by official control laboratories and is low enough to adequately protect the consumers of food commodities that contain that substance. The proposed step‐wise approach considers factors such as analytical capability, toxic potential and pharmacological activity of the substance in question, and includes the identification of the Reasonably Achievable Lowest Limit of Quantification (RALLOQ), the establishment of a Toxicological Screening Value (TSV) and the derivation of a Toxicologically Based Limit of Quantification (TBLOQ). The TBLOQ is compared with the RALLOQ for the respective substance. If the TBLOQ is equal to or higher than the RALLOQ, then the latter can be accepted as the RPA. If the TBLOQ is lower than the RALLOQ, then the sensitivity of the analytical method needs to be improved. In the case where no further analytical improvements are feasible, a substance‐specific risk assessment should be considered. The CONTAM Panel concluded that RPAs should be matrix independent. The CONTAM Panel noted that sometimes non‐edible matrices are monitored to identify the administration of non‐allowed pharmacologically active substances. In these cases, RPAs cannot be applied. The CONTAM Panel also proposed several criteria where the European Commission might consider it appropriate to consult EFSA for a substance‐specific risk assessment.