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Preface: Designing Sampling Plans for Veterinary Drug Residues
In the intricate web of food production, ensuring the safety and quality of products derived from food-producing animals is paramount. This preface introduces the guide for designing sampling plans for veterinary drug residues, an essential component to safeguard public health and ensure compliance with European regulations, specifically, Commission Delegated Regulation (EU) 2022/2292.[MEJ(1]
Regulatory Context
The mentioned regulation outlines the standards governing the presence of residues of pharmacologically active substances, pesticides and contaminants in tissues from animals destined for food production. This document serves as a complementary tool, providing a clear and practical framework for the effective implementation of sampling plans for residues of pharmacologically active substances (i.e., substances present in veterinary medicines).
Scientific Foundations
The guide is grounded in scientific principles and risk assessment approaches, as evidenced by the guidelines from the Codex Committee on Residues of Veterinary Drugs in Food and research supporting a risk-based approach to developing sampling plans.
Contribution to Food Safety
The primary purpose of this guide is to contribute to food safety, offering professionals in the sector practical tools to design effective sampling plans in compliance with established regulatory standards.
We trust that this guide will be a valuable resource for those involved in the food chain, promoting practices that ensure safe and high-quality products for European consumers.
🌐 Sources
Chapter 1:
Toxicological Aspects and Sampling Plan
Chapter 1:
Toxicological Aspects and Sampling Plan
chapter 1.pdf1. Type of Medication: Consider CAC/GL 71-2009, emphasizing the importance of evaluating the type of veterinary medicine used, categorizing by action, and understanding associated risks [1].
2. Duration of Treatment: Refer to CAC/GL 71-2009, highlighting the significance of treatment duration and its impact on residues in food, connecting it with the toxicological risk for consumers [1].
3. Administered Dose: Connect with point 3 of CAC/GL 71-2009, emphasizing the critical factor of medication dosage and the risk of excessive dosages in food [1].
4. Withdrawal Period: Align with point 4 of CAC/GL 71-2009, focusing on the importance of withdrawal periods to ensure residues do not exceed safe levels, referencing regulatory compliance [1].
5.Accumulation Potential: Relate to CAC/GL 71-2009, stressing the risk associated with the accumulation potential of certain veterinary medications in animal tissues [1].
6. Intrinsic Toxicity: Connect with point 6 of CAC/GL 71-2009, emphasizing the critical factor of intrinsic toxicity of drugs and its influence on the risk to human health [1].
7. Possible Metabolites: Reference point 7 of CAC/GL 71-2009, highlighting the importance of considering whether medications break down into toxic metabolites, contributing to residues in food [1].
8. Target Species: Align with point 8 of CAC/GL 71-2009, emphasizing the relevance of the type of animal for which the medicine is intended and its impact on toxicological risk classification [1].
9. Antimicrobial Resistance: Refer to point 9 of CAC/GL 71-2009, underlining the major concern of antimicrobial resistance and its implications for food safety and public health [1].
10. Waste Stability: Connect with point 10 of CAC/GL 71-2009, emphasizing the relevance of drug residue stability in foods and its impact on long-term toxicological risk [1].
11. Regulations and Tolerance Limits: Align with point 11 of CAC/GL 71-2009, stressing the essential consideration of regulations and tolerance limits established by health authorities in evaluating toxicological risk
Chapter 2:
Use of Veterinary Drugs and Sampling Plan
Chapter 2:
Use of Veterinary Drugs and Sampling Plan
1. Clinical Need: Consider CAC/GL 71-2009, emphasizing the importance of determining the clinical need for administering veterinary drugs based on a thorough evaluation of animal health [1].
2. Medication Selection: Align with point 2 of CAC/GL 71-2009, highlighting the significance of choosing appropriate and authorized medications for specific animal species [1].
3. Responsible Veterinarian: Refer to point 3 of CAC/GL 71-2009, emphasizing the role of a veterinarian in prescribing and supervising the use of medications in farm animals [1].
4. Dosage and Administration: Connect with point 4 of CAC/GL 71-2009, emphasizing precise dosage and administration according to manufacturer's recommendations and veterinarian's instructions [1].
5. Registration and Documentation: Relate to point 5 of CAC/GL 71-2009, stressing the essential need to keep detailed records of all medications administered to animals for tracking and traceability [1].
6. Withdrawal Time: Align with point 6 of CAC/GL 71-2009, emphasizing the critical importance of respecting withdrawal times to avoid residues in meat, milk, or other animal products [1].
7. Regulatory Compliance: Reference point 7 of CAC/GL 71-2009, underlining the essential need to comply with local and national regulations related to the use of veterinary medicines in food-producing animals [1].
8. Education and Training: Connect with point 8 of CAC/GL 71-2009, emphasizing the importance of providing adequate training to animal food producers on the responsible use of veterinary medicines [1].
9. Promotion of Alternatives: Relate to point 9 of CAC/GL 71-2009, stressing the promotion of practices that reduce the need for veterinary medications, including improving living conditions and disease prevention [1].
Chapter 3:
Pharmacokinetic Criteria and Sampling Plan
Chapter 3:
Pharmacokinetic Criteria and Sampling Plan
Absorption: Consider CAC/GL 71-2009, emphasizing the importance of understanding drug absorption for designing a risk-based sampling plan [1].
Distribution: Align with CAC/GL 71-2009, highlighting the relevance of considering how drugs move through the body after absorption for risk-based sampling [1].
Metabolism: Relate to CAC/GL 71-2009, stressing the importance of understanding drug metabolism in the body and its impact on tissue sample selection [1].
Elimination: Connect with CAC/GL 71-2009, emphasizing the significance of the elimination process in excreting drugs or metabolites and its relevance to tissue sample selection [1].
Withdrawal Time: Reference point 5 of CAC/GL 71-2009, underlining the critical role of withdrawal time in food safety and tissue sample selection [1].
Specific Species: Align with CAC/GL 71-2009, emphasizing the need for a risk-based sampling plan tailored to the characteristics of each animal
Chapter 4:
Methods of Analysis.
Chapter 4:
Methods of Analysis.
The determination of residues of veterinary drugs in animal tissues involves various analytical techniques aimed at ensuring food safety and compliance with established regulations. These techniques encompass chromatographic, spectroscopic, and immunological methods, emphasizing the need for a multifaceted approach to address the diversity of substances present.
Chromatographic techniques, such as high-performance liquid chromatography (HPLC) and gas chromatography (GC), are widely used. HPLC allows for the precise separation and quantification of different compounds in a sample, while GC is effective for analyzing volatile compounds. Both are crucial for the specific detection of drug residues.
Spectroscopy, particularly mass spectrometry (MS), is used to identify and quantify specific compounds. The coupling of techniques, such as HPLC-MS, enhances the selectivity and sensitivity of the analyses. Additionally, nuclear magnetic resonance spectroscopy (NMR) can also be applied to provide structural information about compounds present in samples.
Immunological techniques, such as enzyme-linked immunosorbent assays (ELISA), are effective in detecting specific residues by leveraging the antigen-antibody interaction. These methods are rapid and sensitive, providing qualitative and quantitative results.
Molecular hybridization techniques, like real-time polymerase chain reaction (qPCR), enable the detection of specific genetic material from microorganisms or drug residues, offering a complementary perspective to traditional chemical techniques.
Captura de pantalla 2023-12-26 a las 19.25.14.pdfIn summary, the determination of residues of veterinary drugs in animal tissues benefits from a variety of analytical techniques, each with its specific advantages. The combination of chromatographic, spectroscopic, and immunological methods offers a comprehensive approach to ensure accurate results and compliance with regulatory standards, ensuring the safety of animal-derived food products.
The effective date of Regulation (EU) 2021/808 was 10/06/2021. Therefore, analysis methods validated from that date onward must comply with its requirements. However, a transition period of 5 years until 10/06/2026 is granted to adapt existing methods. During this period, points 2 and 3 of Annex I of CD 2002/657/EC regarding Operating and Validation Criteria will remain in effect.
Regarding the differences and novelties of Regulation (EU) 2021/808 compared to Commission Decision 2002/657/EC, we can summarize:
2Captura de pantalla 2023-12-26 a las 19.24.46.pdfIt jointly considers the operation of analytical methods, their quality control, and sampling.
It updates the types of limits, including the Level of Interest, NMC (Minimum Calibrated Level), and VRI (Value for Reference for Intervention) replacing the MRPL (Minimum Required Performance Limit).
It updates and includes new analytical techniques for confirmation, such as HPLC-DAD and HPLC-FLD only for authorized substances, high-resolution MS: TOF, Orbitrap, and UPLC.
It incorporates the use of internal isotope standards or compounds analogous to the analyte, co-chromatography, and standards added to matrix extracts or enriched matrix.
It updates criteria for TR, TRR, and Ion Ratios.
It incorporates the study of Relative Matrix Effect and Absolute Recovery.
It redefines acceptance ranges for Accuracy for residues greater than 10µg/kg.
It redefines Coefficients of Variation in Precision assays.
It modifies working ranges for Accuracy, Repeatability, and Intra-laboratory Reproducibility assays.
It incorporates a calculation method for the Decision Limit CCα.
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