DECRETO 30 marzo 2016 - Proroga della scadenza delle autorizzazioni dei prodotti biocidi appartenenti al PT 14 ed aventi come principi attivi il flocoumafen, e/o il brodifacoum e/o il warfarin. (16A02952)
IL DIRETTORE GENERALE dei dispositivi medici e del servizio farmaceutico Visto il regolamento (UE) n. 528/2012 del Parlamento europeo e del Consiglio del 22 maggio 2012, relativo alla messa a disposizione sul mercato e all'uso dei biocidi;
Visto che i principi attivi flocoumafen, brodifacoum e warfarin sono stati inclusi nell'allegato I della direttiva 98/8/CE del Parlamento europeo e del Consiglio per poter essere utilizzati nei biocidi per tipo di prodotto 14 e, a norma dell'articolo 86 del regolamento (UE) n. 528/2012, sono considerati approvati ai sensi del medesimo regolamento, fatte salve le specifiche e le condizioni di cui all'allegato I della direttiva summenzionata;
Visto che la scadenza della loro approvazione sulla base delle rispettive direttive di inclusione era prevista al 30 settembre 2016 per il flocoumafen e al 31 gennaio 2017 per il brodifacoum e il warfarin;
Vista la decisione di esecuzione (UE) 2016/135 della Commissione del 29 gennaio 2016 che posticipa la data di scadenza dell'approvazione del flocoumafen, brodifacoum e warfarin destinati ad essere utilizzati nei biocidi del tipo di prodotto 14 al 30 giugno 2018;
Visto il documento CA-Sept14-Doc 5.2-Final nel quale la Commissione europea, al fine di consentire alle aziende titolari di autorizzazioni di prodotti biocidi rientranti nel tipo di prodotto 14 contenenti principi attivi la cui scadenza e' stata...
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