El cambiante marco legislativo para las sustancias y productos biocidas en la UE ha transformado en los últimos 24 meses de forma significativa la formulación, el uso y la comercialización de uno de los grupos de biocidas más comunes en el control de plagas urbanas: los rodenticidas.
Por una parte, con la actualización del Reglamento (CE) nº 1272/2008 sobre clasificación, etiquetado y envasado de sustancias y mezclas químicas (CLP), que entró en vigor el año pasado, los rodenticidas anticoagulantes con concentración de 30ppm o superior han quedado clasificados como productos reprotóxicos (categoría CMR). Por otra parte, el programa de revisión de sustancias activas biocidas, creado por la Comisión Europea bajo la Directiva de Productos Biocidas (BPD) y que continúa bajo el actual Reglamento 528/2012 sobre productos biocidas (BPR), ha supuesto cambios en los registros de los productos formulados con estas materias activas.
La suma de las novedades de ambas legislaciones nos ha dejado un panorama muy distinto en el mercado de los rodenticidas en la UE, del que Inés Rodríguez, directora de la empresa especializada en la distribución de productos biocidas Sanitrade, nos comenta a continuación los cambios más relevantes que se han producido y su impacto a nivel técnico y administrativo.
1. APARICIÓN DE NUEVAS FORMULACIONES
Hasta hace menos de 2 años los productos rodenticidas formulados con anticoagulantes habían mantenido constantes las concentraciones de materia activa desde su invención:
La entrada en vigor de la actualización del Reglamento europeo CLP, que reclasifica como CMRs los productos formulados con sustancias activas anticoagulantes con concentración igual o superior a 30ppm, ha dado lugar a la aparición de nuevos productos:
- Formulados con flocoumafen menor a 30ppm
- Formulados con brodifacoum menor a 30ppm
- Formulados con bromadiolona menor a 30ppm
- Formulados con difenacoum menor a 30ppm
En este escenario, hay que destacar los rodenticidas formulados con la sustancia activa anticoagulante difetialona, que siempre han estado formulados a 25ppm. La difetialona es la única materia activa que se formula, desde su invención en 1989, a 25ppm.
Por otra parte, además de estos rodenticidas anticoagulantes, existen en el mercado español rodenticidas con otras sustancias activas no anticoagulantes, como la alfacloralosa, actualmente presente en formulación al 4%, a los que no afecta la reclasificación del Reglamento europeo CLP, y por tanto no están sujetas a las restricciones de las que hablaremos a continuación.
2. RESTRICCIONES DE FORMULACIONES CON ANTICOAGULANTES
Vamos a ver cuales son los cambios y restricciones que ha supuesto la reclasificación de los anticoagulantes como CMRs en concentraciones iguales o superiores a 30ppm:
- Sólo se permite su uso por profesionales especializados: hasta marzo de 2018 podían ser comprados por el público en general o profesionales (ganaderos). A partir de entonces se reduce su uso a usuarios con formación específica en biocidas, pero no sólo eso…
- Además, el Responsable Técnico y los técnicos aplicadores que los utilicen deberán tener el carnet oficial de Muy Tóxicos y CMRs
- El almacén donde se ubiquen estos biocidas deberá estar adaptado para el almacenamiento de productos tóxicos para la reproducción (si se almacenan cantidades >1000 kg.)
- El ROESB debe alcanzar el almacenamiento y servicio, respectivamente, de productos tóxicos para la reproducción.
- Las operaciones de comercialización y aplicación de productos clasificados A1 o A2 deben serinscritos en el LOMB (Libro Oficial de Movimientos Biocidas)
3. ¿SON EFICACES LOS RODENTICIDAS NO SUJETOS A ESTAS RESTRICCIONES?
Los formulados de difetialona, que ya existían a 25ppm, y que no han cambiado su formulación, siguen teniendo, obviamente, la misma eficacia como rodenticida de ingesta única (segunda generación) y sin resistencias conocidas.
Respecto a los nuevos formulados de flocoumafen, brodifacoum, bromadiolona y difenacoum, la bajada de concentración entre un 40-50%, puede tener consecuencias desiguales dependiendo de la materia activa:
- En el caso de los rodenticidas anticoagulantes de primera generación, existe falta de eficacia en formulaciones con concentración inferior a 30ppm.
- En el caso de rodenticidas anticoagulantes de segunda generación, puede existir un aumento de los tiempos de eliminación al ser necesaria la ingestión de una cantidad mayor de cebo.
- En el caso de bromadiolona y difenacoum, que son rodenticidas con resistencias conocidas tanto en ratas como en ratones, con una concentración menor a 30ppm la ingesta para lograr eficacia, en caso de resistencia, daría lugar a falta de eficacia del tratamiento.
- En el caso del brodifacoum, con resistencia conocida en ratones, una concentración menor a 30ppm, la ingesta para lograr eficacia, en caso de resistencia, daría lugar a falta de eficacia del tratamiento.
- En el caso del flocoumafen, rodenticida de segunda generación y sin resistencias conocidas, su único formulador asegura que los tiempos de eliminación se mantienen, ya que, en su nueva formulación, el refuerzo de la palatabilidad con nuevos ingredientes, hace que el incremento del 25-30% de ingesta requerido se logre con el incremento de atracción de su nueva formulación.
4. CAMBIOS EN LOS REGISTROS: USOS Y TIPOS DE APLICACIÓN
Si en los puntos anteriores nos referíamos a las implicaciones administrativas y técnicas de los formulados, en función de su concentración de materia activa, también es necesario mirar a los registros de TODOS LOS RODENTICIDAS, porque los cambios derivados del Reglamento (UE) nº 528/2012 son GRANDES.
En los registros se especifica:
- Los lugares de uso del producto (interior, alrededor de edificios, áreas abiertas, vertederos y medios de transporte). Esta nueva clasificación de lugares de uso sustituye a la anterior distinción entre Sanidad Ambiental e Industria Alimentaria, que deja de aplicarse en los nuevos registros según el Reglamento (UE) nº 528/2012.
- El uso de rodenticidas debe estar incluido en un Plan de Control integrado de plagas incluyendo medidas físicas y de higiene.
- SE PROHIBE EL CEBADO PERMANTE. Eso significa que su uso sólo debe realizarse cuando exista certeza de plaga mediante la monitorización.
- Los productos no deben utilizarse más de 35 días sin una evaluación del estado de la infestación y la eficacia del tratamiento.
- Cantidades de cebo/caja portacebos en función del grado de infestación definidas en cada registro.
- Distancia entre cajas portacebos en función del grado de infestación, según lo definido en cada registro.
- Información a transeúntes de campañas de desratización (cuando sea posible).
- Los portacebos deben etiquetarse con la siguiente información: “no mover o abrir”, “contiene un rodenticida”, “nombre del producto o número de autorización, “sustancia(s) activa(s)”, “en caso de accidente, llame al SERVICIO DE INFORMACIÓN TOXICOLÓGICA (Teléfono 915620420)”.
5. CAMBIOS EN LA GESTIÓN DE RESIDUOS
- Retirar el producto sobrante al final del periodo de tratamiento (contrato).
- Al final del tratamiento se debe eliminar el cebo no consumido y el envase (portacebos al final de su vida útil) a través de un gestor de residuos peligrosos autorizados.
- Eliminar los roedores muertos a través de un gestor de residuos peligrosos autorizados, de acuerdo con la normativa vigente: Residuos Peligrosos.
No existe un código específico para estos residuos, por su origen, a falta de otro más apropiado se podrían incluir en LER 20 01 99 “Otras fracciones no especificadas en otra categoría” considerándolo un residuo peligroso, ya que LOS ROEDORES SE TIENEN QUE CLASIFICAR COMO LOS PRODUCTOS QUE INGIEREN. Se recomienda como método de tratamiento la incineración.
En general, es muy importante leer detenidamente el Registro del producto antes de su aplicación porque cada registro contiene además especificidades sobre el producto, medidas complementarias en el plan de control de plaga, e incluso como tratar los portacebos (por ej. “No lavar los portacebos […] entre aplicaciones”)
EN RESUMEN
El cambio de clasificación CLP hace que los requisitos para utilizar la mayoría de los productos hasta ahora utilizados se hayan multiplicado, por el incremento de nivel de peligrosidad de los anticoagulantes. Eso ha llevado a la aparición de nuevos productos exentos de estos requisitos cuya eficacia y consecuencias en el medio y largo plazo está por determinar.
Además, la evaluación europea de todos los anticoagulantes ha traído nuevas restricciones en el uso de los productos (necesidad de monitorización, prohibición de cebado permanente, tratamiento por un máximo de 35 días, delimitación por registro de las cantidades de cebo a utilizar y el número de puntos de cebo, obligación de incluir medidas físicas y de higiene en programa de control, etc).
Por todo ello, los programas de control de roedores deberán ser más dirigidos y con mayores evaluaciones, siguiendo la línea que ya se inició hace algunos años con el control de insectos.
Aunque a priori podría parecer que estos cambios son un hándicap para los programas de desratización, también pueden verse como una oportunidad para la diferenciación de los profesionales, la mayor profesionalización del sector, la puesta en valor de la calidad del servicio, y el objetivo de lograr una sostenibilidad mayor a largo plazo.
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