Decisión de Ejecución (UE) 2018/1985 de la Comisión, de 13 de diciembre de 2018, por la que no se aprueba Willaertia magna c2c maky como sustancia activa para su uso en biocidas del tipo de producto 11
Section | Decisión de ejecución |
Issuing Organization | Comisión de las Comunidades Europeas |
14.12.2018 ES Diario Oficial de la Unión Europea L 317/27
LA COMISIÓN EUROPEA,
Visto el Tratado de Funcionamiento de la Unión Europea,
Visto el Reglamento (UE) n.o 528/2012 del Parlamento Europeo y del Consejo, de 22 de mayo de 2012, relativo a la comercialización y el uso de los biocidas (1), y en particular su artículo 9, apartado 1, letra b),
Considerando lo siguiente:
(1) La autoridad competente evaluadora de Francia recibió, el 17 de marzo de 2014, una solicitud de aprobación del microorganismo Willaertia magna c2c maky para su uso como sustancia activa en biocidas del tipo de producto 11, conservantes para líquidos utilizados en sistemas de refrigeración y en procesos industriales, según se describe en el anexo V del Reglamento (UE) n.o 528/2012.
(2) La autoridad competente evaluadora de Francia presentó el informe de evaluación con sus conclusiones el 15 de marzo de 2017, de conformidad con el artículo 8, apartado 1, del Reglamento (UE) n.o 528/2012.
(3) El 26 de abril de 2018, el Comité de Biocidas presentó el dictamen de la Agencia Europea de Sustancias y Mezclas Químicas teniendo en cuenta las conclusiones de la autoridad competente evaluadora (2).
(4) Con arreglo a dicho dictamen, no puede esperarse que los biocidas del tipo de producto 11 que contienen Willaertia magna c2c maky cumplan los criterios establecidos en el artículo 19, apartado 1, letra b), del Reglamento (UE) n.o 528/2012. En particular, los escenarios analizados en la evaluación de los riesgos para la salud humana pusieron de manifiesto riesgos inaceptables y no fue posible identificar ningún uso seguro. Además, no quedó suficientemente probada la eficacia natural de Willaertia magna c2c maky para controlar la Legionella pneumophila.
(5) Teniendo en cuenta el dictamen de la Agencia Europea de Sustancias y Mezclas Químicas, la Comisión no considera apropiado aprobar Willaertia magna c2c maky para su uso en...
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