DECRETO 25 gennaio 2013 - Attuazione della decisione della Commissione europea n. 2012/728/UE del 23 novembre 2012, concernente la non iscrizione del bifentrin per il tipo di prodotto 18 negli allegati I, IA o IB della direttiva 98/8/CE del Parlamento europeo e del Consiglio, relativa all'emissione sul mercato di biocidi, e conseguente revoca dell'autorizzazione di alcuni presidi medico-chirurgici. (13A01460)
IL DIRETTORE GENERALE dei dispositivi medici, del servizio farmaceutico e della sicurezza delle cure Visto il decreto legislativo del 25 febbraio 2000, n. 174, recante «Attuazione della direttiva 98/8/CE in materia di immissione sul mercato di biocidi»;
Visto il decreto del Presidente della Repubblica 6 ottobre 1998, n. 392, recante norme per la semplificazione dei procedimenti di autorizzazione alla produzione ed all'immissione in commercio dei presidi medico-chirurgici, a norma dell'art. 20, comma 8, della legge 15 marzo 1997, n. 59;
Visto il regolamento (CE) n. 1451/2007 della Commissione del 4 dicembre 2007, concernente la seconda fase del programma di lavoro decennale di cui all'art. 16, paragrafo 2, della direttiva 98/8/CE del Parlamento europeo e del Consiglio relativa all'immissione sul mercato dei biocidi;
Considerato che ai sensi del regolamento (CE) n. 1451/2007, il bifentrin (n. CAS 82657-04-3) e' stato esaminato in conformita' all'articolo 11, paragrafo 2, della direttiva 9818/CE ai fini del suo utilizzo nel tipo di prodotto 18 che comprende insetticidi, acaricidi e prodotti destinati al controllo degli altri artropodi, come definito nell'allegato V della medesima direttiva;
Considerato che la valutazione ha dimostrato che i biocidi utilizzati come insetticidi, acaricidi e prodotti destinati al controllo degli altri artropodi e contenenti bifentrin non possono soddisfare i requisiti di cui all'articolo 5 della direttiva 98/8/CE e che gli scenari esaminati nella valutazione dei rischi per la salute umana nonche' nella valutazione dei rischi per l'ambiente hanno rivelato un rischio potenziale e inaccettabile;
Vista la decisione della Commissione europea n. 2012/728/CE del 23 novembre 2012, pubblicata nella Gazzetta Ufficiale dell'Unione europea il 27 novembre 2012, concernente la non iscrizione del...
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