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JECFA Toolbox for Veterinary Drug Residues Risk Assessment

Section 5. Deriving maximum residue limits (MRLs)











FAO. 2024. JECFA Toolbox for Veterinary Drug Residues Risk Assessment – Section 5. Deriving maximum residue limits (MRLs)Rome.



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    Booklet
    JECFA Toolbox for Veterinary Drug Residues Risk Assessment
    Section 0. Introduction and outline
    2024
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    The use of veterinary drugs in food-producing animals can leave residues that may pose a risk to consumers when they consume animal-derived food products. A rigorous scientific assessment can help mitigate these risks while facilitating the international trade of animal-derived food products.Consult the guidance document on the introduction to the JECFA veterinary drug residue risk assessment process to: • get an overview of the purpose and content of the toolbox; • understand how JECFA interacts with other agencies, participants and stakeholders in the broader veterinary drug residue risk analyses; and• read a Q&A on the Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF) and JECFA.This publication is part of the FAO JECFA Toolbox for Veterinary Drug Residue Risk Assessment. The toolbox provides practical guidance on the principles, modalities and technical requirements of JECFA in assessing the risks of veterinary drug residues in food and in recommending MRLs.
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    Booklet
    JECFA Toolbox for Veterinary Drug Residues Risk Assessment
    Section 3.3. Marker residue depletion studies
    2024
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    A radiolabelled study may not represent the “real-world” use of the drug. Therefore, the ensuing total residue depletion data may not accurately predict real-world residue concentrations. To determine likely “real-world” drug residues, it is necessary to conduct a separate marker residue depletion study. Consult the guidance document on marker residue depletion studies to: • understand why a marker residue depletion study is required in addition to a total residue study;• learn about the characteristics of a well-performed marker residue depletion study; • find relevant guidance documents regarding marker residue depletion study design and analytical methodology; and• access a hypothetical data set to begin practicing drug residue depletion data analysis.This publication is part of the FAO JECFA Toolbox for Veterinary Drug Residue Risk Assessment. The toolbox provides practical guidance on the principles, modalities and technical requirements of JECFA in assessing the risks of veterinary drug residues in food and in recommending MRLs.
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    Booklet
    JECFA Toolbox for Veterinary Drug Residues Risk Assessment
    Section 4.2. JECFA’s approach for assessing dietary exposure to veterinary drug residues: Estimating dietary exposure using global estimated chronic dietary exposure (GECDE) and global estimated acute dietary exposure (GEADE)
    2024
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    JECFA uses a novel, data-driven process for predicting the amounts of animal-derived food products consumed by people. This process has significant impacts on the resulting drug residue exposure assessment. In this guidance document you will: • learn about the food intake processes used by JECFA and their use in the subsequent exposure estimates (global estimated chronic/acute dietary exposure; GECDE/GEADE); and• incorporate residue depletion data (average or high-level residues) from animal-derived food products with dietary food intake estimates to predict acute (GEADE) and chronic (GECDE) exposure to veterinary drug residues, using the skills learned in Section 3.This publication is part of the FAO JECFA Toolbox for Veterinary Drug Residue Risk Assessment. The toolbox provides practical guidance on the principles, modalities and technical requirements of JECFA in assessing the risks of veterinary drug residues in food and in recommending MRLs.

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