The DIRECTOR-GENERAL of medical devices and pharmaceutical service having regard to Regulation (EC) 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; Considering that, in accordance with article 9 of Regulation (EC) No 528/2012, the Commission shall adopt regulations establishing the approval of active substances and the conditions of inclusion in annex of the said regulations; Having regard to the Decree of the President of the Republic October 6, 1998, # 392 in the authorization procedure for the production and placing on the market of medical; See, in particular, article 89, paragraph 3 of Regulation (EC) No 528/2012; Given the need for change, for the free sale and medical products for which has been made requiring permission as a biocide, two years as indicated in the decrees below to revoke the ban on the marketing and provide for them, instead of the two-year period mentioned above cannot be marketed, sold or passed on to the final consumer after three hundred and sixty five days from the date of approval of these active substances; Given the directorial Decree March 18, 2014, recante: "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 product type 2", published in the Gazzetta Ufficiale della Repubblica italiana n. 82 of April 8, 2014; Given the 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; Given the directorial Decree 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; Given the directorial Decree 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; Given the directorial Decree March 18, 2014, recante: "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; Given the directorial Decree March 18, 2014, recante: "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; Given the directorial Decree March 18, 2014, recante: "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; Given the directorial Decree March 18, 2014, recante: "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; Given the directorial Decree March 18, 2014, recante: "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; Given the directorial Decree March 18, 2014, recante: "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; See the press release on the start of the procedure for evaluating the opportunity to change ten directorial decrees transposing Commission implementing regulations concerning biocidal products relating to the active ingredients of copper sulfate penta hydrate, benzoic acid, IPBC, etofenprox, Aluminium phosphide, nonanoic acid, bromacetico acid, Cypermethrin, Propiconazole, tebuconazole, published in the official journal-General Series-# 16 of 21-1-2015, against which no comments were received or comments; Considering also that by adopting Regulation (EC) No 334/2014 of the European Parliament and of the Council of March 11, 2014, art. 89 of regulation 528/2012 has been modified, with the deletion of the word "disposal" (in English "disposal"); Considered, therefore, that as a result of that deleting the period specified in the third paragraph, lett. b) of art. 89 use of stocks of the biocidal product must be reported; Considered, therefore, to establish that the products of free sale and medical for which has been made requiring permission as biocide and whose inclusion rules have been released since the entry into force of Regulation (EU) No. 334/2014, they can't be marketed, sold or disposed of to the final consumer after 180 days from the date of approval of these active substances;
Decrees: Art. 1 correction of directorial decrees of March 18, 2014 concerning medical and freely sold 1. For medical and free sale products falling within the scope of directorial decrees mentioned in the introduction, a period of two years from the date of approval of the active substance for the placing on the market, sale and sale to the final consumer for products that are not supported, it is replaced by the term of 365 days from the date of approval of the active substance, after which the medical are considered revoked and the products may not be sold and transferred to the consumer.