Reglamento de Ejecución (UE) 2020/1712 de la Comisión de 16 de noviembre de 2020 por el que se modifica el Reglamento (UE) n.o 37/2010 para clasificar la sustancia lidocaína por lo que respecta a su límite máximo de residuos (Texto pertinente a efectos del EEE)
Section | Serie L |
Issuing Organization | Comisión de las Comunidades Europeas |
17.11.2020 ES Diario Oficial de la Unión Europea L 384/3
(1) De conformidad con el artículo 17 del Reglamento (CE) n.o 470/2009, debe establecerse en un reglamento el límite máximo de residuos (LMR) de las sustancias farmacológicamente activas destinadas a utilizarse en la Unión en medicamentos veterinarios para animales productores de alimentos o en biocidas empleados en la cría de animales.
(2) En el cuadro 1 del anexo del Reglamento (UE) n.o 37/2010 de la Comisión (2) figuran las sustancias farmacológicamente activas y su clasificación por lo que se refiere a los LMR en los productos alimenticios de origen animal.
(3) La lidocaína ya está incluida en dicho cuadro como sustancia autorizada para équidos, únicamente para anestesia local y regional. La entrada existente tiene una clasificación «no se exige LMR».
(4) Se ha presentado a la Agencia Europea de Medicamentos («la Agencia») una solicitud de ampliación a porcinos de la entrada existente relativa a la lidocaína, únicamente para uso cutáneo y epilesional en lechones de hasta siete días de edad.
(5) También se ha presentado a la Agencia una solicitud para ampliar a bovinos la entrada existente relativa a la lidocaína, aplicable a músculo, grasa, hígado, riñón y leche.
(6) La Agencia, basándose en los dictámenes del Comité de Medicamentos de Uso Veterinario, ha recomendado el establecimiento de un LMR para la lidocaína en bovinos, pero ha llegado a la conclusión de que el establecimiento de un LMR para la lidocaína en porcinos de cierta edad y para determinados usos no es necesario para la protección de la salud humana.
(7) De conformidad con el artículo 5 del Reglamento (CE) n.o 470/2009, la Agencia debe considerar la posibilidad de...
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