Procedure For Evaluating The Opportunity To Modify Diecidecreti Directorial Commission's Transposition Of The Regulations Concerning Biocide Esecuzionedella Attivisolfato Principles Of Copper Penta Hydrate, Benzoic Acid, Ipbc, E. ..

Original Language Title: Procedimento di valutazione dell'opportunita' di modificare diecidecreti direttoriali di recepimento dei regolamenti di esecuzionedella Commissione in materia di biocidi concernenti i principi attivisolfato di rame penta idrato, acido benzoico, IPBC, e...

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-21&atto.codiceRedazionale=15A00346&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Please note that the Directorate General of medical devices and pharmaceutical service of the Ministry of health has initiated an administrative procedure to evaluate the opportunity to modify the following directorial decrees concerning biocidal products: 1) decreto direttoriale March 18, 2014 laying: "Provisions resulting from the enactment of the implementing Regulation (EU) no 1033/2013 of October 24, 2013, approving copper sulfate as existing active substance intended for use in biocidal products of type of product 2 ", published in the Gazzetta Ufficiale della Repubblica italiana n. 82 of April 8, 2014;
2) directorial Decree March 18, 2014, recante: "Provisions resulting from the enactment of the implementing Regulation (EU) No 1035/2013 of October 24, 2013, approving the benzoic acid as existing active substance intended for use in biocidal products of type 3 and 4", published in the Gazzetta Ufficiale della Repubblica italiana n. 82 of April 8, 2014;
3) decreto direttoriale March 18, 2014, recante: "Provisions resulting from the enactment of the implementing Regulation (EU) no 1037/2013 of October 24, 2013, approving the IPBC as existing active substance intended for use in biocidal products product type 6", published in the Gazzetta Ufficiale della Repubblica italiana No 82 of April 8, 2014;
4) decreto direttoriale March 18, 2014, recante: "Provisions resulting from the enactment of the implementing Regulation (EU) no 1036/2013 of October 24, 2013, approving etofenprox as existing active substance intended for use in biocidal products of type of product 18", published in the Gazzetta Ufficiale della Repubblica italiana n. 82 of April 8, 2014;
March 18, 2014 5) directorial Decree laying down: "Provisions resulting from the enactment of the implementing Regulation (EU) no 1034/2013 of October 24, 2013, approving Aluminium phosphide releasing phosphine as existing active substance intended for use in biocidal products product type 20", published in the Gazzetta Ufficiale della Repubblica italiana No 82 of April 8, 2014;
6) directorial Decree March 18, 2014 laying: "Provisions resulting from the enactment of the implementing Regulation (EU) no 1039/2013 of October 24, 2013, approving the nonanoic acid as existing active substance intended for use in biocidal products product type 2", published in the Gazzetta Ufficiale della Repubblica italiana n. 82 of April 8, 2014;
7) directorial Decree March 18, 2014 laying: "Provisions resulting from the enactment of the implementing Regulation (EU) no 1032/2013 of October 24, 2013, approving the bromoacetic acid as existing active substance intended for use in biocidal products of type of product 4", published in the Gazzetta Ufficiale della Repubblica italiana n. 82 of April 8, 2014;
8) March 18, 2014 directorial Decree laying down: "Provisions resulting from the enactment of the implementing Regulation (EU) No 945/2013 of October 2, 2013, approving the Cypermethrin as existing active substance intended for use in biocidal products of type 8", published in the Gazzetta Ufficiale della Repubblica italiana n. 82 of April 8, 2014;
9) directorial Decree March 18, 2014 laying: "Provisions resulting from the enactment of the implementing Regulation (EU) No 955/2013 of October 4, 2013, approving Propiconazole as existing active substance intended for use in biocidal products product type 9", published in the Gazzetta Ufficiale della Repubblica italiana n. 81 of April 7, 2014;
March 18, 2014 directorial Decree laying down 10): "Provisions resulting from the enactment of the implementing Regulation (EU) no 1038/2013 of October 24, 2013, approving the tebuconazole as existing active substance intended for use in biocidal products of type of product 7 and 10", published in the Gazzetta Ufficiale della Repubblica italiana n. 81 of April 7, 2014.
The initiation of the procedure builds upon doubts of interpretation of art. 89 of Regulation No 528/2012 of the European Parliament and of the Council of May 22, 2012 concerning the making available on the market and use of biocidal products, in the version in force at the date of adoption of these decrees.
In this regard, it is particularly significant that by adopting Regulation (EU) No. 334/Parliament and Council of March 11, 2014 2014, art. 89 of regulation 528/2012 has been modified, even with the deletion of the reference to the word "disposal" (in English "disposal") by the third paragraph, governing the authorisation of products on the market regime for which no permission was required as a biocide within the period of the date of approval of its active ingredient. Only with that deleting it became clear that the term "disposal" was not referred to the presence in the stock market the product until they run out, but their treatment as residues.
Given that, in light of the doubt interpretation, there would seem to be a possible divergence between the terms granted in the aforementioned decrees and the deadlines imposed by art. 89, the procedure is intended to assess whether the conditions regulatory and opportunity to amend articles 1, paragraph 1 and 2, paragraph 1 of the aforementioned decrees.
With regard to medical products for which has been made requiring permission as a biocide, it is the exam assessing the opportunity to change the two-year period mentioned above, providing that the date of the approval of its active ingredient, permissions are revoked after 180 days and its products cannot be placed on the market , sold or transferred to the final consumer after three hundred and sixty five days.
As regards products of free sale for which has been made requiring permission as a biocide, it is the exam assessing the opportunity to provide that with effect from the approval of the active substance, instead of two years as previously indicated, products cannot be marketed, sold or disposed of to the final consumer after three hundred and sixty five days.
All interested parties are invited to submit, within 30 days from the date of publication in the Official Gazette of this press release, any comments, memories or documents considered relevant for the purpose of the proceedings by certified mail to the address dgfdm@postacert.sanita.it.