Reglamento de Ejecución (UE) 2021/412 de la Comisión, de 8 de marzo de 2021, que modifica el Reglamento de Ejecución (UE) 2017/962 en lo que respecta a la revisión de la suspensión de la autorización de la etoxiquina como aditivo en piensos
Section | Serie L |
Issuing Organization | Comisión de las Comunidades Europeas |
9.3.2021 ES Diario Oficial de la Unión Europea L 81/30
(1) Mediante el Reglamento de Ejecución (UE) 2017/962 de la Comisión (2) se suspendió la autorización del aditivo etoxiquina tomando como base el dictamen de la Autoridad Europea de Seguridad Alimentaria («Autoridad») de 21 de octubre de 2015 (3), que no pudo llegar a una conclusión sobre la seguridad y la eficacia del aditivo debido a la falta general de datos presentados por el solicitante en el marco del procedimiento de autorización.
(2) La autorización del aditivo etoxiquina se suspendió a la espera de la presentación y la evaluación de los datos complementarios que debía facilitar el solicitante, de conformidad con un calendario que enumeraba por orden de prioridad los estudios que debían llevarse a cabo sucesivamente. Según dicho calendario, el resultado del último de esos estudios estaría disponible en julio de 2018.
(3) De conformidad con el Reglamento de Ejecución (UE) 2017/962, la medida de suspensión debe revisarse a más tardar el 31 de diciembre de 2020, tras la oportuna evaluación de los datos complementarios requeridos.
(4) Si bien el solicitante ha presentado sucesivos paquetes de datos complementarios, se han producido importantes retrasos en la generación de una serie de datos, en particular en relación con la demostración de la seguridad del aditivo etoxiquina para el medio ambiente. Entre las razones de estos retrasos cabe citar la necesidad de iniciar nuevos estudios para cumplir los requisitos específicos en materia de datos establecidos en el Reglamento (CE) n.o 429/2008 de la Comisión (4) y las correspondientes directrices detalladas de la Autoridad, así como las dificultades para encontrar laboratorios o instalaciones de ensayo adecuados para la realización de determinados estudios.
(5) El solicitante presentó por última vez datos complementarios sobre la evaluación del riesgo para el medio ambiente en septiembre de 2020. En función del resultado de la evaluación por parte de...
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