| Code (a) | Commodity | Existing MRL (b) | Data gap(s) Art.12 Review | Proposed MRL | Conclusion/recommendation |
|---|---|---|---|---|---|
| Enforcement residue definition: Thiabendazole | |||||
| 0130010 | Apples | 4(ft1) | Footnote related to data gaps No 3 and No 9 | 4 | The data gaps identified by EFSA concerning potential consumer exposure to the metabolite benzimidazole (from food and feed) have been addressed for this GAP (post‐harvest). The MRL is confirmed. No consumer intake concerns identified. The previous consumer risk assessment remains valid. |
| 0163010 | Avocados | 20 (ft2) | Footnote related to data gap No 4 | 7 or 15 (Further risk management considerations required) | The data gap identified by EFSA concerning the lack of GAP‐compliant residue trials has been addressed by means of an adjusted GAP and new residue trials. The resulting MRL (7 mg/kg) is lower than the existing tentative EU MRL of 20 mg/kg. An alternative MRL proposal based on the Codex MRL (15 mg/kg) was also identified. Risk for consumers is unlikely for the calculated MRL and for the Codex MRL. |
| 0211000 | Potatoes | 0.04 (ft3) | Footnote related to data gaps No 2, No 3 and No 9 | 0.04 | The data gap identified by EFSA concerning the storage stability of the metabolite benzimidazole has been addressed. The data gaps identified by EFSA concerning potential consumer exposure to the metabolite benzimidazole (from food and feed) have been addressed for this GAP (seed treatment). The MRL is confirmed. No consumer intake concerns identified. The previous consumer risk assessment remains valid. |
| Enforcement residue definition: Sum of thiabendazole and 5‐hydroxythiabendazole, expressed as thiabendazole | |||||
| 1011010 | Swine Muscle | 0.05* (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* |
The updated livestock dietary burden indicates that for EU PPP uses of thiabendazole no residues above the LOQ are expected. The MRL proposal at the LOQ is supported by the available data and the risk for consumers is unlikely. There are no CXLs for these commodities. 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requirement for information on the magnitude of residues of the metabolite benzimidazole has not been addressed but is superseded by the revised livestock dietary burden calculation where no residues above the LOQ of 0.01 mg/kg are expected to occur in swine commodities. |
| 1011020 | Swine Fat | 0.05* (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1011030 | Swine Liver | 0.15 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1011040 | Swine Kidney | 0.3 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1011050 | Swine Edible offals (other than liver and kidney) | 0.3 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1012010 | Bovine Muscle | 0.1 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* or 0.1 (Further risk management considerations required) |
The updated livestock dietary burden indicates that for EU PPP uses of thiabendazole no residues above the LOQ are expected. An MRL proposal at the LOQ is supported by the available data and 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 for the Codex MRLs of 0.1 mg/kg, on which the existing EU MRL is based. An MRL proposal reflecting the veterinary MRL of 0.1 mg/kg implemented by Commission Regulation 37/2010 can be considered by risk managers. Risk for consumers is unlikely for the Veterinary MRLs and for the Codex MRLs with regard to thiabendazole, however no risk assessment could be done for benzimidazole residues potentially associated to these MRLs. |
| 1012020 | Bovine Fat | 0.1 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* or 0.1 (Further risk management considerations required) | |
| 1012030 | Bovine Liver | 0.3 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* or 0.1 (Further risk management considerations required) |
The updated livestock dietary burden indicates that for EU PPP uses of thiabendazole no residues above the LOQ are expected. The MRL proposal at the LOQ is supported by the available data and 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 for the Codex MRLs (0.3 and 1 mg/kg) on which the existing EU MRLs are based. An MRL proposal reflecting the veterinary MRL of 0.1 mg/kg implemented by Commission Regulation 37/2010 can be considered by risk managers. Risk for consumers is unlikely for the Veterinary MRLs and for the Codex MRLs with regard to thiabendazole, however no risk assessment could be done for benzimidazole residues potentially associated to these MRLs. |
| 1012040 | Bovine Kidney | 1 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* or 0.1 (Further risk management considerations required) | |
| 1012050 | Bovine Edible offals (other than liver and kidney) | 1 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* or 0.1 (Further risk management considerations required) | |
| 1013010 | Sheep Muscle | 0.05* (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | The updated livestock dietary burden indicates that for EU PPP uses of thiabendazole no residues above the LOQ are expected. The MRL proposal at the LOQ is supported by the available data and the risk for consumers is unlikely. There are no CXLs for these commodities. 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 is superseded by the revised livestock dietary burden calculation where no residues above the LOQ of 0.01 mg/kg are expected to occur in sheep commodities. |
| 1013020 | Sheep Fat | 0.05* (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1013030 | Sheep Liver | 0.15 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1013040 | Sheep Kidney | 0.3 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1013050 | Sheep Edible offals (other than liver and kidney) | 0.3 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1014010 | Goat Muscle | 0.1 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* or 0.1 (Further risk management considerations required) |
The updated livestock dietary burden indicates that for EU PPP uses of thiabendazole no residues above the LOQ are expected. An MRL proposal at the LOQ is supported by the available data and the risk for consumers is unlikely. There are no CXLs for these commodities. 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 is superseded by the revised livestock dietary burden calculation where no residues above the LOQ of 0.01 mg/kg are expected to occur in goat commodities. An MRL proposal reflecting the veterinary MRL of 0.1 mg/kg implemented by Commission Regulation 37/2010 can be considered by risk managers. Risk for consumers is unlikely for the Veterinary MRLs with regard to thiabendazole, however no risk assessment could be done for benzimidazole residues potentially associated to these MRLs. |
| 1014020 | Goat Fat | 0.1 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* or 0.1 (Further risk management considerations required) | |
| 1014030 | Goat Liver | 0.15 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* or 0.1 (Further risk management considerations required) | |
| 1014040 | Goat Kidney | 0.3 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* or 0.1 (Further risk management considerations required) | |
| 1014050 | Goat Edible offals (other than liver and kidney) | 0.3 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* or 0.1 (Further risk management considerations required) | |
| 1015010 | Equine Muscle | 0.05* (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | The updated livestock dietary burden indicates that for EU PPP uses of thiabendazole no residues above the LOQ are expected. The MRL proposal at the LOQ is supported by the available data and the risk for consumers is unlikely. There are no CXLs for these commodities. 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 is superseded by the revised livestock dietary burden calculation where no residues above the LOQ of 0.01 mg/kg are expected to occur in equine commodities. |
| 1015020 | Equine Fat | 0.05* (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1015030 | Equine Liver | 0.15 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1015040 | Equine Kidney | 0.3 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1015050 | Equine Edible offals (other than liver and kidney) | 0.3 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1,016,010 | Poultry Muscle | 0.05 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 |
0.01* |
The updated livestock dietary burden indicates that for EU PPP uses of thiabendazole no residues above the LOQ are expected. The MRL proposal at the LOQ is supported by the available data and 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 for the Codex MRLs of 0.05 mg/kg on which the existing EU MRL is based. Risk for consumers is unlikely for the for the Codex MRLs with regard to thiabendazole, however no risk assessment could be done for benzimidazole residues potentially associated to these MRLs. |
| 1016020 | Poultry Fat | 0.05 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1016030 | Poultry Liver | 0.2 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | The updated livestock dietary burden indicates that for EU PPP uses of thiabendazole no residues above the LOQ are expected. The MRL proposal at the LOQ is supported by the available data and the risk for consumers is unlikely. There are no CXLs for these commodities. 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 is superseded by the revised livestock dietary burden calculation where no residues above the LOQ of 0.01 mg/kg are expected to occur in these commodities. |
| 1016040 | Poultry Kidney | 0.2 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1016050 | Poultry Edible offals (other than liver and kidney) | 0.2 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1017010 | Other farmed terrestrial animals: Muscle | 0.05* (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1017020 | Other farmed terrestrial animals: Fat | 0.05* (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1017030 | Other farmed terrestrial animals: Liver | 0.15 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1017040 | Other farmed terrestrial animals: Kidney | 0.3 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| 1017050 | Other farmed terrestrial animals: Edible offals (other than liver and kidney) | 0.3 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* | |
| Enforcement residue definition: sum of thiabendazole, 5‐hydroxythiabendazole and its sulfate conjugate, expressed as thiabendazole | |||||
| 1020010 | Milk Cattle | 0.2 (ft4) | Footnote related to data gaps No 7, No 3 and No 9 | 0.01* or 0.1 (Further risk management considerations required) |
The updated livestock dietary burden indicates that for EU PPP uses of thiabendazole no residues above the LOQ are expected. The MRL proposal at the LOQ is supported by the available data and 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 for the Codex MRLs of 0.2 mg/kg, on which the existing EU MRL is based. An MRL proposal reflecting the veterinary MRL of 0.1 mg/kg implemented by Commission Regulation 37/2010 can be considered by risk managers. Risk for consumers is unlikely for the Veterinary MRL and for the Codex MRL with regard to thiabendazole, however no risk assessment could be done for benzimidazole residues potentially associated to these MRLs |
| 1,020,020 | Milk Sheep | 0.2 (ft4) | Footnote related to data gaps No 7, No 3 and No 9 | 0.01* | The updated livestock dietary burden indicates that for EU PPP uses of thiabendazole no residues above the LOQ are expected. The MRL proposal at the LOQ is supported by the available data and the risk for consumers is unlikely. There is no CXL for this commodity. 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 is superseded by the revised livestock dietary burden calculation where no residues above the LOQ of 0.01 mg/kg are expected to occur in sheep milk. |
| 1020030 | Milk Goat | 0.2 (ft4) | Footnote related to data gaps No 7, No 3 and No 9 | 0.01* or 0.1 (Further risk management considerations required) |
The updated livestock dietary burden indicates that for EU PPP uses of thiabendazole no residues above the LOQ are expected. The MRL proposal at the LOQ is supported by the available data and the risk for consumers is unlikely. There is no CXL for this commodity. 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 is superseded by the revised livestock dietary burden calculation where no residues above the LOQ of 0.01 mg/kg are expected to occur in goat milk. An MRL proposal reflecting the veterinary MRL of 0.1 mg/kg implemented by Commission Regulation 37/2010 can be considered by risk managers. Risk for consumers is unlikely for the Veterinary MRL with regard to thiabendazole, however no risk assessment could be done for benzimidazole residues potentially associated to this MRL. |
| 1020040 | Milk Horse | 0.2 (ft4) | Footnote related to data gaps No 7, No 3 and No 9 | 0.01* | The updated livestock dietary burden indicates that for EU PPP uses of thiabendazole no residues above the LOQ are expected. The MRL proposal at the LOQ is supported by the available data and the risk for consumers is unlikely. There are no CXLs for these commodities. 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 is superseded by the revised livestock dietary burden calculation where no residues above the LOQ of 0.01 mg/kg are expected to occur in horse milk and other milks. |
| 1020990 | Milk Others | 0.2 (ft4) | Footnote related to data gaps No 7, No 3 and No 9 | 0.01* | |
| Enforcement residue definition: Sum of thiabendazole and 5‐hydroxythiabendazole, expressed as thiabendazole | |||||
| 1030000 | Birds eggs | 2 (ft4) | Footnote related to data gaps No 6, No 3 and No 9 | 0.01* |
The updated livestock dietary burden indicates that for EU PPP uses of thiabendazole no residues above the LOQ are expected. The MRL proposal at the LOQ is supported by the available data and the risk for consumers is unlikely. The confirmatory data requirement for information on analytical methods has been addressed. There is a Codex MRL of 0.1 mg/kg for this commodity but the confirmatory data requirement for information on the magnitude of residues of the metabolite benzimidazole would also apply to this CXL and it has not been addressed. Risk for consumers is unlikely for the for the Codex MRL with regard to thiabendazole, however no risk assessment could be done for benzimidazole residues potentially associated to this MRL. |
MRL: maximum residue level; NEU: northern Europe; SEU: southern Europe; GAP: Good Agricultural Practice; LOQ: limit of quantification; CXL: Codex maximum residue limit.
Commodity code number according to Annex I of Regulation (EC) No 396/2005.
Existing EU MRL and corresponding footnote on confirmatory data.
ft 1: 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.
ft 2: The European Food Safety Authority identified some information on residue trials 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.
ft 3: 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.
ft 4: 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.