Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole
Abstract The applicant Corteva Agrosciences submitted a request to the competent national authority in Slovenia to evaluate the confirmatory data that were identified for fenbuconazole in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-08-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2023.8205 |
| _version_ | 1797679293163110400 |
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| author | European Food Safety Authority (EFSA) Giulia Bellisai Giovanni Bernasconi Luis Carrasco Cabrera Irene Castellan Monica del Aguila Lucien Ferreira German Giner Santonja Luna Greco Samira Jarrah Renata Leuschner Javier Martinez Perez Ileana Miron Stefanie Nave Ragnor Pedersen Hermine Reich Silvia Ruocco Miguel Santos Alessia Pia Scarlato Anne Theobald Manuela Tiramani Alessia Verani |
| author_facet | European Food Safety Authority (EFSA) Giulia Bellisai Giovanni Bernasconi Luis Carrasco Cabrera Irene Castellan Monica del Aguila Lucien Ferreira German Giner Santonja Luna Greco Samira Jarrah Renata Leuschner Javier Martinez Perez Ileana Miron Stefanie Nave Ragnor Pedersen Hermine Reich Silvia Ruocco Miguel Santos Alessia Pia Scarlato Anne Theobald Manuela Tiramani Alessia Verani |
| author_sort | European Food Safety Authority (EFSA) |
| collection | DOAJ |
| description | Abstract The applicant Corteva Agrosciences submitted a request to the competent national authority in Slovenia to evaluate the confirmatory data that were identified for fenbuconazole in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the Article 12 confirmatory data gaps, new residue trials analysing triazole derivative metabolites (TDMs) were submitted on grapefruits, lemons, apples, pears, peaches, cherries and blueberries. Following the assessment of submitted data, EFSA concluded that Article 12 confirmatory data gaps are considered addressed for grapefruits, oranges, lemons, limes, pome fruits, peaches, cherries and blueberries. The calculated livestock dietary burdens indicated that for the individual TDMs, the trigger value of 0.004 mg/kg bw day is not exceed from the intake of apple pomace and citrus dried pulp. The new information provided required the assessment of consumer exposure to TDMs, which identified no consumer intake concerns for the crops under consideration. No data were submitted to address the Article 12 confirmatory data gaps for tree nuts, apricots, plums, table grapes, wine grapes, cranberries, bananas, sweet peppers/bell peppers, cucurbits with edible/inedible peel, peanuts/groundnuts, sunflower seeds and rapeseeds/canola seeds, barley, rye and wheat. For these commodities, the existing EU MRL could be lowered to the enforcement LOQ. |
| first_indexed | 2024-03-11T23:12:26Z |
| format | Article |
| id | doaj.art-6136885ef5ee4280bc6808b3e5e6fe83 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-03-11T23:12:26Z |
| publishDate | 2023-08-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-6136885ef5ee4280bc6808b3e5e6fe832023-09-21T06:30:44ZengWileyEFSA Journal1831-47322023-08-01218n/an/a10.2903/j.efsa.2023.8205Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazoleEuropean Food Safety Authority (EFSA)Giulia BellisaiGiovanni BernasconiLuis Carrasco CabreraIrene CastellanMonica del AguilaLucien FerreiraGerman Giner SantonjaLuna GrecoSamira JarrahRenata LeuschnerJavier Martinez PerezIleana MironStefanie NaveRagnor PedersenHermine ReichSilvia RuoccoMiguel SantosAlessia Pia ScarlatoAnne TheobaldManuela TiramaniAlessia VeraniAbstract The applicant Corteva Agrosciences submitted a request to the competent national authority in Slovenia to evaluate the confirmatory data that were identified for fenbuconazole in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the Article 12 confirmatory data gaps, new residue trials analysing triazole derivative metabolites (TDMs) were submitted on grapefruits, lemons, apples, pears, peaches, cherries and blueberries. Following the assessment of submitted data, EFSA concluded that Article 12 confirmatory data gaps are considered addressed for grapefruits, oranges, lemons, limes, pome fruits, peaches, cherries and blueberries. The calculated livestock dietary burdens indicated that for the individual TDMs, the trigger value of 0.004 mg/kg bw day is not exceed from the intake of apple pomace and citrus dried pulp. The new information provided required the assessment of consumer exposure to TDMs, which identified no consumer intake concerns for the crops under consideration. No data were submitted to address the Article 12 confirmatory data gaps for tree nuts, apricots, plums, table grapes, wine grapes, cranberries, bananas, sweet peppers/bell peppers, cucurbits with edible/inedible peel, peanuts/groundnuts, sunflower seeds and rapeseeds/canola seeds, barley, rye and wheat. For these commodities, the existing EU MRL could be lowered to the enforcement LOQ.https://doi.org/10.2903/j.efsa.2023.8205fenbuconazoleconfirmatory datapesticideMRL reviewrisk assessment |
| spellingShingle | European Food Safety Authority (EFSA) Giulia Bellisai Giovanni Bernasconi Luis Carrasco Cabrera Irene Castellan Monica del Aguila Lucien Ferreira German Giner Santonja Luna Greco Samira Jarrah Renata Leuschner Javier Martinez Perez Ileana Miron Stefanie Nave Ragnor Pedersen Hermine Reich Silvia Ruocco Miguel Santos Alessia Pia Scarlato Anne Theobald Manuela Tiramani Alessia Verani Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole EFSA Journal fenbuconazole confirmatory data pesticide MRL review risk assessment |
| title | Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole |
| title_full | Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole |
| title_fullStr | Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole |
| title_full_unstemmed | Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole |
| title_short | Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole |
| title_sort | evaluation of confirmatory data following the article 12 mrl review for fenbuconazole |
| topic | fenbuconazole confirmatory data pesticide MRL review risk assessment |
| url | https://doi.org/10.2903/j.efsa.2023.8205 |
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