Codea | Commodity | Existing EU MRL (mg/kg) | Proposed EU MRL (mg/kg) | Comment/justification |
---|---|---|---|---|
Enforcement residue definition: thiabendazole | ||||
0110000 | Citrus fruits | 7 ft1 | 7 | The submitted data are sufficient to calculate an MRL of 5 mg/kg for the intended post‐harvest EU GAP. The revised livestock dietary burden considering also the more critical uses for citrus fruits supporting the existing MRL (Codex MRL) and the updated input values for other feed commodities as implemented in Commission Regulation 2017/1164 indicate that residues in animal commodities would not occur above the LOQ of 0.01 mg/kg. Therefore, the levels of benzimidazole in animal matrices that result from pesticide uses would be insignificant. The requirement for confirmatory information on the magnitude of residues of the metabolite benzimidazole has been superseded by the revised livestock dietary burden calculation. The MRL proposal reflects the existing EU MRL derived from the Codex MRL (7 mg/kg). Risk for consumers unlikely. |
0163020 | Bananas | 6 | No change | The submitted data are sufficient to derive an MRL of 6 mg/kg for the intended post‐harvest GAP. The derived MRL is identical to the existing EU MRL. Risk for consumers unlikely. |
0163030 | Mangoes | 0.01* | 5 or 7 | The submitted data are sufficient to derive an import tolerance of 7 mg/kg in support of the authorised post‐harvest GAP for dip application (Guatemala, Belize, Honduras, Panama, Dominican Republic, Nicaragua, Costa Rica GAP). The calculated import tolerance is higher than the MRL in force in the exporting countries (Codex MRL: 5 mg/kg). It is noted that the 2019 Extra JMPR estimated a higher Codex MRL of 7 mg/kg for thiabendazole in mangoes that has not yet been adopted by the Codex Alimentarius Commission. Risk for consumers unlikely. |
0212020 | Sweet potatoes | 0.01* | 3 | The submitted data are sufficient to calculate an import tolerance of 3 mg/kg in response to the authorised emergency exemption GAP for post‐harvest spray application (USA). Risk for consumers unlikely. The MRL in force in the exporting country is a time‐limited tolerance in response to an emergency exemption authorisation at the level of 10 mg/kg determined according to the USA residue definition for enforcement: sum of thiabendazole and benzimidazole (free and conjugated), expressed as thiabendazole. |
0255000 | Witloofs/Belgian endives | 0.05* ft2 | 0.15 | The submitted data are sufficient to calculate an MRL of 0.15 mg/kg for the intended indoor GAP (pre‐harvest use). The residue definition for risk assessment also includes the metabolite benzimidazole (free and conjugated), however the submitted residue trials demonstrate that benzimidazole is not expected to occur at levels above the LOQ of 0.01 mg/kg. The lack of validation of the analytical method for the determination of conjugates is considered a minor deficiency. The residue trial data are considered fully valid with regard to the storage stability of thiabendazole and were judged to be acceptable with regard to the storage stability of benzimidazole (minor deficiency) and therefore the requirement for confirmatory information on storage stability has been addressed. The requirement for confirmatory information on the magnitude of residues of the metabolite benzimidazole has been superseded by the revised livestock dietary burden calculation. Risk for consumers unlikely. |
Enforcement residue definition: sum of thiabendazole and 5‐hydroxythiabendazole, expressed as thiabendazole | ||||
1011010 | Swine Muscle | 0.05* ft3 | 0.01 * | The available data are sufficient to derive an MRL proposal at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed but has been superseded by the revised livestock dietary burden calculation where the MRL is proposed at the LOQ of 0.01 mg/kg. |
1011020 | Swine Fat | 0.05* ft3 | 0.01 * | |
1011030 | Swine Liver | 0.15 ft3 | 0.01 * | |
1011040 | Swine Kidney | 0.3 ft3 | 0.01 * | |
1011050 | Swine Edible offals (other than liver and kidney) | 0.3 ft3 | 0.01 * | |
1012010 | Bovine Muscle | 0.1 ft3 | 0.1 (ft) | The available data are sufficient to derive an MRL at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed. The MRL proposal reflects the veterinary MRL of 0.1 mg/kg implemented by Commission Regulation 37/2010. Risk managers may consider to implement the MRLs of 0.1 mg/kg on the basis of Codex MRLs which are not sufficiently supported by data and should be re‐considered in the framework of confirmatory data assessment. If risk managers decide to set the MRL on the basis of the veterinary MRL the footnote for confirmatory data can be deleted. |
1012020 | Bovine Fat | 0.1 ft3 | 0.1 (ft) | |
1012030 | Bovine Liver | 0.3 ft3 | 0.1 or 0.3 (ft) Further risk management considerations required | The available data are sufficient to derive an MRL at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed. Risk managers may consider to lower the MRL to the level of the veterinary MRL of 0.1 mg/kg implemented by Commission Regulation 37/2010 or to maintain the existing EU MRLs derived from Codex MRLs which are not sufficiently supported by data and should be re‐considered in the framework of confirmatory data assessment. If risk managers decide to set the MRL at the level of the veterinary MRL the footnote for confirmatory data can be deleted. |
1012040 | Bovine Kidney | 1 ft3 | 0.1 or 1 (ft) Further risk management considerations required | |
1012050 | Bovine Edible offals (other than liver and kidney) | 1 ft3 | 0.1 or 1 (ft) Further risk management considerations required | |
1013010 | Sheep Muscle | 0.05* ft3 | 0.01 * | The available data are sufficient to derive an MRL proposal at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed but has been superseded by the revised livestock dietary burden calculation where the MRL is proposed at the LOQ of 0.01 mg/kg. |
1013020 | Sheep Fat | 0.05* ft3 | 0.01 * | |
1013030 | Sheep Liver | 0.15 ft3 | 0.01 * | |
1013040 | Sheep Kidney | 0.3 ft3 | 0.01 * | |
1013050 | Sheep Edible offals (other than liver and kidney) | 0.3 ft3 | 0.01 * | |
1014010 | Goat Muscle | 0.1 ft3 | 0.1 | The available information is sufficient to derive an MRL at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed. The MRL proposal reflects the veterinary MRL of 0.1 mg/kg implemented by Commission Regulation No 37/2010. EFSA proposed to remove the footnote since for the veterinary MRL no confirmatory data are required. |
1014020 | Goat Fat | 0.1 ft3 | 0.1 | |
1014030 | Goat Liver | 0.15 ft3 | 0.1 | |
1014040 | Goat Kidney | 0.3 ft3 | 0.1 | |
1014050 | Goat Edible offals (other than liver and kidney) | 0.3 ft3 | 0.1 | The available information is sufficient to derive an MRL at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed. The MRL proposal reflects the veterinary MRLs of 0.1 mg/kg for liver and kidney implemented by Commission Regulation No 37/2010. EFSA proposed to remove the footnote since for the veterinary MRL no confirmatory data are required. |
1015010 | Equine Muscle | 0.05* ft3 | 0.01 * | The available data are sufficient to derive an MRL proposal at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed but has been superseded by the revised livestock dietary burden calculation where the MRL is proposed at the LOQ of 0.01 mg/kg. |
1015020 | Equine Fat | 0.05* ft3 | 0.01 * | |
1015030 | Equine Liver | 0.15 ft3 | 0.01 * | |
1015040 | Equine Kidney | 0.3 ft3 | 0.01 * | |
1015050 | Equine Edible offals (other than liver and kidney) | 0.3 ft3 | 0.01 * | |
1016010 | Poultry Muscle | 0.05 ft3 | 0.01 * or 0.05 (ft) Further risk management considerations required | The available data are sufficient to derive an MRL proposal at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed but has been superseded by the revised livestock dietary burden calculation where the MRL is proposed at the LOQ of 0.01 mg/kg. Risk managers may consider to lower the MRL to the level of the LOQ of 0.01 mg/kg or to maintain the existing MRLs derived from Codex MRLs which are not sufficiently supported by data and should be re‐considered in the framework of confirmatory data assessment. |
1016020 | Poultry Fat | 0.05 ft3 | 0.01 * or 0.05 (ft) Further risk management considerations required | |
1016030 | Poultry Liver | 0.2 ft3 | 0.01 * | The available data are sufficient to derive an MRL proposal at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed but has been superseded by the revised livestock dietary burden calculation where the MRL is proposed at the LOQ of 0.01 mg/kg. |
1016040 | Poultry Kidney | 0.2 ft3 | 0.01 * | |
1016050 | Poultry Edible offals (other than liver and kidney) | 0.2 ft3 | 0.01 * | |
1017010 | Other farmed terrestrial animals: Muscle | 0.05* ft3 | 0.01 * | |
1017020 | Other farmed terrestrial animals: Fat | 0.05* ft3 | 0.01 * | |
1017030 | Other farmed terrestrial animals: Liver | 0.15 ft3 | 0.01 * | |
1017040 | Other farmed terrestrial animals: Kidney | 0.3 ft3 | 0.01 * | |
1017050 | Other farmed terrestrial animals: Edible offals (other than liver and kidney) | 0.3 ft3 | 0.01 * | |
Enforcement residue definition: sum of thiabendazole, 5‐hydroxythiabendazole and its sulfate conjugate, expressed as thiabendazole | ||||
1020010 | Milk Cattle | 0.2 ft3 | 0.1 or 0.2 (ft) Further risk management considerations required | The available data are sufficient to derive an MRL at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed. Risk managers may consider to lower the MRL to the level of the veterinary MRL of 0.1 mg/kg implemented by Commission Regulation 37/2010 or to maintain the existing MRL derived from the Codex MRL which is not sufficiently supported by data and should be re‐considered in the framework of confirmatory data assessment. If risk managers decide to set the MRL at the level of the veterinary MRL the footnote for confirmatory data can be deleted. |
1020020 | Milk Sheep | 0.2 ft3 | 0.01 * | The available data are sufficient to derive an MRL proposal at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed but has been superseded by the revised livestock dietary burden calculation where the MRL is proposed at the LOQ of 0.01 mg/kg. |
1020030 | Milk Goat | 0.2 ft3 | 0.1 | The available information is sufficient to derive an MRL at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed. The MRL proposal reflects the veterinary MRL of 0.1 mg/kg implemented by Commission Regulation No 37/2010. EFSA proposed to remove the footnote since for the veterinary MRL no confirmatory data are required. |
1020040 | Milk Horse | 0.2 ft3 | 0.01 * | The available data are sufficient to derive an MRL proposal at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed but has been superseded by the revised livestock dietary burden calculation where the MRL is proposed at the LOQ of 0.01 mg/kg. |
1020990 | Milk Others | 0.2 ft3 | 0.01 * | |
Enforcement residue definition: sum of thiabendazole and 5‐hydroxythiabendazole, expressed as thiabendazole | ||||
1030000 | Birds eggs | 2 ft3 | 0.01 * or 0.1 (ft) Further risk management considerations required | The available data are sufficient to derive an MRL proposal at the LOQ of 0.01 mg/kg on the basis of the updated EU livestock dietary burden, which is supported by the available data and for which the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. The confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed but has been superseded by the revised livestock dietary burden calculation where the MRL is proposed at the LOQ of 0.01 mg/kg. Risk managers may consider to lower the MRL to the level of the LOQ of 0.01 mg/kg or to lower the MRL to the level of the Codex MRL which is not sufficiently supported by data and should be re‐considered in the framework of confirmatory data assessment. |
MRL: maximum residue level; GAP: Good Agricultural Practice.
Indicates that the MRL is set at the limit of analytical quantification (LOQ).
Commodity code number according to Annex I of Regulation (EC) No 396/2005.
0110000 Citrus fruits: The European Food Safety Authority identified some information on the magnitude of residues of the metabolite benzimidazole as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 1 July 2019, or, if that information is not submitted by that date, the lack of it.
0255000 Witloofs/Belgian endives: The European Food Safety Authority identified some information on storage stability and on the magnitude of residues of the metabolite benzimidazole as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 1 July 2019, or, if that information is not submitted by that date, the lack of it.
1000000 Products of Animal Origin ‐Terrestrial Animals: The European Food Safety Authority identified some information on analytical methods and on the magnitude of residues of the metabolite benzimidazole as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 1 July 2019, or, if that information is not submitted by that date, the lack of it.