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Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (Text with EEA relevance)
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There are outstanding changes not yet made to Commission Regulation (EU) 2018/782. Any changes that have already been made to the legislation appear in the content and are referenced with annotations.
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include a clear position on the adequacy of the data presented, in light of current scientific knowledge;
have an introduction describing the actual or proposed pattern of use of the substance under review in animal husbandry and a summary of any other experience of its use;
consider the extent to which the substance concerned has similarities to other known substances, which may be relevant for the evaluation;
cover all standard data requirements, as set out in the Commission Implementing Regulation (EU) 2017/12(1), provide a critical evaluation of the available experimental studies and an interpretation of the results;
provide scientific justification for the omission of any studies that are described in this section;
discuss requirements for additional studies;
provide a description and explanation of the key findings for each study. The following issues shall be discussed: the animal species used, the number(s) of animals used, the route(s) of administration, the dosage(s), the duration of treatment, the exposure achieved, the dose response relationship, the nature of the adverse effects (their onset and duration, their dose dependency and reversibility and any species related or sex-related differences), known relevant structure-activity relationships and relevance of the findings for human consumers;
give a justification for the NO(A)EL or LO(A)EL or BMDL proposed for each study;
summarise and discuss relevant scientific literature, including reports of evaluations undertaken by other scientific bodies (such as the European Food Safety Authority (‘EFSA’), European Chemicals Agency (‘ECHA’) and the Joint Food and Agriculture Organisation (‘FAO’)/World Health Organisation (‘WHO’) Expert Committee on Food Additives (‘JECFA’)). If detailed references to published scientific literature are used, all the requirements set out under point I.5 shall be met, as far as possible;
include information on the quality of batches of test substances used in the safety studies. Any association between findings and the quality of the test substances and/or the medicinal products shall be indicated. When necessary, a critical evaluation of the impurities present in the active ingredient shall be presented and information on their potential biological effects shall be given. The implications of any differences of the chirality, chemical form and impurity profile between the substance used in the safety studies and the form to be marketed shall be discussed;
discuss the GLP status of the studies submitted;
discuss possible deficiencies in the design and conduct of the studies and their documentation, making reference to published Agency and other guidance. Any deviations from applicable guidance shall be highlighted and the impact of the deviation discussed and scientifically justified;
comment on the use of experimental animals in the studies and whether the studies were conducted in accordance with Directive 2010/63/EU;
provide a justification for the selection of critical NO(A)EL(s) or BMDL(s) and the derivation of the acceptable daily intake (‘ADI’), justifying the selection of uncertainty factors. If no ADI is proposed, or if an alternative toxicological reference value is selected, this shall be thoroughly justified.
list of references — a list of all references shall be provided in accordance with internationally accepted standards. The references themselves shall be included in the dossier;
tabulated study reports — tabular summaries of study reports. In addition, a complete set of study reports shall be included in the dossier.
enable to identify/characterise the mode/mechanism of action of the substance;
enable characterisation of the dose-response relationship for relevant pharmacological endpoints;
provide insight into the potential toxic effects of the substance based on knowledge of known effects of other substances with similar pharmacodynamic properties;
aid the understanding of the mechanisms underlying adverse effects seen in toxicology studies;
provide, in certain cases, information on the relevance of effects seen in laboratory animals for humans.
allow the evaluation of the functional and morphological changes due to repeated administration of the test substance(s) and how these changes are related to dose;
allow the establishment of a NO(A)EL or LO(A)EL or BMDL;
inform the choice of dose levels for chronic studies as well as the choice of the most appropriate species for chronic studies.
the evaluation of the functional and morphological changes due to repeated administration of the test substance(s) and how these changes are related to dose;
the establishment of a NO(A)EL or LO(A)EL or BMDL.
the structure of the substance and its similarity to substances with known toxicological effects;
the class of the substance and known toxicological properties of other substances in the class;
the mode of action of the substance;
any effects seen in the standard toxicity studies that warrant further investigation (e.g. immunotoxicity, neurotoxicity or endocrine dysfunction);
the existence of published literature highlighting relevant findings, including literature relating to effects seen in humans exposed to the substance.
disruption of the colonisation barrier — the first endpoint of concern shall address the question of whether ingestion of residues of antimicrobiologically active substances in food of animal origin poses a risk to human health resulting from the disruption of the colonisation barrier function of the normal intestinal flora;
increase of the population of resistant bacteria — the second endpoint of concern shall address the question of whether ingestion of residues of antimicrobiologically active substances pose a risk to human health resulting from an increase in the population of resistant bacteria either due to acquisition of resistance by previously sensitive bacteria or to a relative increase in the proportion of less sensitive organisms.
Generally the ADI shall be derived from the pharmacological, toxicological or microbiological data although, where appropriate data exist, it may be derived from human data.
ADI (mg/kg bw/day) = NOAEL or BMDL (mg/kg bw/day) divided by Uncertainty Factor
Separate pharmacological, toxicological and microbiological ADIs shall be derived, as appropriate and the overall ADI (i.e. the ADI used in the risk assessment and in the setting of MRLs) shall generally be the lowest of the pharmacological, toxicological and microbiological ADIs.
For substances that may induce non-threshold effects, such as genotoxic carcinogens, derivation of a NO(A)EL or BMDL is not possible due to the uncertainty in establishing a threshold for these effects. For such substances an ADI cannot be derived.
For some substances it may not be possible nor meaningful to establish an ADI. In such situations, alternatives to ADI may be used.
Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L 4, 7.1.2017, p. 1).
Approach to establish a pharmacological acceptable daily intake (ADI) (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001530.jsp&mid=).
VICH GL47 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: laboratory animal comparative metabolism studies (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001515.jsp&mid=WC0b01ac058002dd37).
VICH GL33 Safety studies for veterinary drug residues in human food: general approach to testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001480.jsp&mid=WC0b01ac058002dd37).
VICH GL31 Safety studies for veterinary drug residues in human food: repeat-dose (90) toxicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001478.jsp&mid=WC0b01ac058002dd37).
VICH GL37 Safety of veterinary drugs in human food repeat-dose (chronic) toxicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001481.jsp&mid=WC0b01ac058002dd37).
VICH GL22 Safety studies for veterinary drug residues in human food: reproduction studies (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001475.jsp&mid=WC0b01ac058002dd37).
VICH GL32 Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001479.jsp&mid=WC0b01ac058002dd37).
VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001476.jsp&mid=WC0b01ac058002dd37).
VICH GL46 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: metabolism study to determine the quantity and identify the nature of residues (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001516.jsp&mid=WC0b01ac058002dd37).
Review of the Threshold of Toxicological Concern (TTC) approach and development of new TTC decision tree (http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2016.EN-1006/epdf).
VICH GL28 Studies to evaluate the safety of veterinary drugs in human: carcinogenicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001477.jsp&mid=WC0b01ac058002dd37).
OECD Test No 424: Neurotoxicity Study in Rodents (http://www.oecd-ilibrary.org/environment/test-no-424-neurotoxicity-study-in-rodents_9789264071025-en).
OECD Test No 426: Developmental Neurotoxicity Study (http://www.oecd-ilibrary.org/environment/test-no-426-developmental-neurotoxicity-study_9789264067394-en)
OECD Test No 443: Extended One-Generation Reproductive Toxicity Study (http://www.oecd-ilibrary.org/environment/test-no-443-extended-one-generation-reproductive-toxicity-study_9789264185371-en).
OECD Test No 418: Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure (http://www.oecd-ilibrary.org/environment/test-no-418-delayed-neurotoxicity-of-organophosphorus-substances-following-acute-exposure_9789264070905-en).
OECD Test No 419: Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study (http://www.oecd-ilibrary.org/environment/test-no-419-delayed-neurotoxicity-of-organophosphorus-substances-28-day-repeated-dose-study_9789264070929-en).
VICH GL36 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001531.jsp&mid=WC0b01ac058002dd37).
Guidance of the Scientific Committee on Use of the benchmark dose approach in risk assessment (http://www.efsa.europa.eu/en/efsajournal/pub/1150).
Approach to establish a pharmacological acceptable daily intake (ADI) (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001530.jsp&mid=).
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