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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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for mammals other than swine: muscle, fat, liver and kidney;
for swine and poultry: muscle, fat and skin in natural proportions, liver and kidney;
for fin-fish: muscle and skin in natural proportions;
if the substance is proposed for use in a milk producing, egg producing or honey producing species, MRLs shall be recommended for milk, eggs and/or honey, respectively, wherever possible. As for tissues, recommendations for MRLs in milk, eggs and honey shall be based on data demonstrating the residue depletion profile in these commodities. Where no such data are available, it may be considered necessary to reserve an unused portion of the ADI for the future establishment of MRLs in these commodities (Section II.5).
the ADI (or alternative limit if appropriate) — MRLs shall be recommended at levels that ensure that consumer exposure to residues of concern remains below the ADI;
the proposed marker residue;
the ratio of the marker residue to total residues;
the distribution of residues across edible tissues — the individual MRLs proposed for the different edible tissues shall reflect the distribution of residues across these tissues. In those cases where residues in a tissue rapidly fall below the limit of quantification (the smallest measured content of an analyte above which a determination of the analyte can be made with a specified degree of accuracy and precision) of the analytical method, it shall not be possible to establish MRLs that reflect the distribution of residues across tissues. Where this occurs, MRLs shall be set at twice the limit of quantification in order to provide an MRL for use in residue surveillance. Wherever possible, the tissue selected for residue monitoring purposes shall be one in which the MRL was set taking the distribution of residues across tissues into account;
the overall exposure of the consumer to residues — this shall be demonstrated to be below the ADI based on the residue levels seen in the depletion studies, and using the standard food basket (see below).
The standard food basket shall be made up of the quantities of the food commodities shown in the table below:
a Fat and skin in natural proportions for pigs | |||||||
Mammals | Poultry | Fish | Bees | ||||
---|---|---|---|---|---|---|---|
Muscle | 0,300 kg | Muscle | 0,300 kg | Muscle and skin in natural proportions | 0,300 kg | Honey | 0,020 kg |
Fat | 0,050 kga | Fat and skin in natural proportions | 0,090 kg | ||||
Liver | 0,100 kg | Liver | 0,100 kg | ||||
Kidney | 0,050 kg | Kidney | 0,010 kg | ||||
Milk | 1,500 kg | Eggs | 0,100 kg |
Amount per edible tissue or product = (proposed MRL for the tissue or product x (times) daily consumption of the tissue or product)/(divided by) Ratio of the marker to total residue in the tissue or product.
substances of endogenous origin, particularly if exposure to residues has only a minor impact on the overall exposure to the substance;
substances which are essential nutrients or normal constituents of the diet in man and animals;
substances for which no pharmacological activity considered to be biologically relevant has been identified;
substances that have been demonstrated to be of low toxicity following exposure by the oral route;
substances that are not absorbed or are poorly absorbed from the gastro-intestinal tract or from the sites of local application (e.g. skin or eyes);
substances that are rapidly and extensively detoxified or excreted;
substances that have been demonstrated not to result in detectable residues in food derived from treated animals.
The need for the substance in order to avoid unnecessary suffering for target animals or to ensure the safety of those treating them may be relevant factors to consider in those cases where practical treatment alternatives are lacking. These considerations may justify acceptance of a reduced data package in line with the recommendations provided in the Agency's ‘Guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market’(1). These factors may also be considered in relation to the need to set MRLs at levels that will allow development of a product with a practicable withdrawal period, as defined in Directive 2001/82/EC of the European Parliament and of the Council(2).
information relating to the likely usefulness of the substance in other species (e.g. indication in the original species, mechanism of action, known toxicity of the substance in different species);
physico-chemical and pharmacokinetic data that may indicate the likely distribution of the substance to milk, eggs or honey;
whether the intended use of the substance requires MRLs that use up almost the entire ADI and are there particular considerations (such as availability concerns) that would justify recommending MRLs that would limit the possibility for future development of the substance;
consideration of existing uses of the substance in fields other than veterinary medicine, and the consumer exposure that may result from these uses (indicated under Section II.6).
Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001536.jsp&mid=WC0b01ac058002dd38).
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).
Risk characterisation and assessment of maximum residue limits (MRL) for biocides (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001541.jsp&mid=WC0b01ac05804aca04).
Commission Regulation (EU) 2017/880 of 23 May 2017 laying down rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species, in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L 135, 24.5.2017, p. 1).
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