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The GENERAL MANAGER for hygiene and food safety and nutrition having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of February 23, 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC and the subsequent regulations amending annexes II and III to that regulation as regards maximum residue levels for individual active substances in or on certain products; Having regard to Council Regulation (EC) no 1272/2008 of the European Parliament and of the Council of December 16, 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, as amended; Having regard to Council Regulation (EC) No 1107/2009 of the European Parliament and of the Council of October 21, 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and subsequent implementing regulations and/or modification, and in particular art. 80 on "transitional measures"; Having regard to Directive 1999/45/EC of the European Parliament and of the Council of May 31, 1999 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, as amended, for the part still in force; Having regard to Directive 2009/128/EC of the European Parliament and of the Council of October 21, 2009 establishing a framework for Community action to achieve a sustainable use of pesticides; Having regard to the Legislative Decree March 31, 1998, n. 112 on "transfer of administrative functions and tasks of the State to the regions and local authorities, in the implementation of chapter I of law March 15, 1997, # 59", and in particular articles 115 containing "Division of powers" and art. 119 regarding "authorizations"; Having regard to law no 172 on November 13, 2009 "establishment of the Ministry of health and increase the total number of State Secretaries of State" and subsequent amendments; Having regard to the Decree of the President of the Republic March 28, 2013, no. 44 concerning "regulation on the reorganization of collective bodies and other bodies active in the Ministry of health, in accordance with art. 2, paragraph 4, of law November 4, 2010, # 183 "; Having regard to the Decree of the President of the Council of Ministers in February 11, 2014, # 59 on "organisational regulations of the Ministry of health", and in particular art. 10 on the "General Directorate of food safety and nutrition"; Having regard to the Legislative Decree March 17, 1995, n. 194 on "implementation of Directive 91/414/EEC concerning the placing of plant protection products ', as amended; Having regard to the Decree of the President of the Republic April 23, 2001, # 290, regarding "regulation for the simplification of the procedures for authorising the production, placing on the market and sales of plant protection products and related processing", as amended; Having regard to the Legislative Decree March 14, 2003, n. 65, on "implementation of directives 1999/45/EC and 2001/60/EC relating to the classification, packaging and labelling of dangerous preparations, and its subsequent amendments; Having regard to the Legislative Decree of August 14, 2012, n. 150 on "implementing directive 2009/128/EC establishing a framework for Community action to achieve a sustainable use of pesticides '; Having regard to the Ministerial Decree January 22, 2014 on "Adoption of the national action plan for the sustainable use of plant protection products on the market, in accordance with art. 6 of Legislative Decree No August 14, 2012. 150 laying: "implementing directive 2009/128/EC establishing a framework for Community action to achieve a sustainable use of pesticides '; Having regard to the request made on October 17, 2014 by the undertaking Isagro SpA with registered office in Milano, via Caldera, 21, intended to obtain the authorisation of the plant protection product called CYTORAM COMBI WG containing active substances copper and cimoxanil, equal to the reference product called Ramezin Combi WG recorded at # 9010 with D.D. on December 2, 1996 , amended subsequently by decrees whose last on February 28, 2013, of the enterprise; Given that the technical-administrative verification of the Office has established the existence of the requirements for the application of art. 10 of the aforementioned Decree of the President of the Republic April 23, 2001, # 290, in particular that:-the product is equal to the quoted reference product Ramezin Combi WG recorded at # 9010; Detected so it's not requested the opinion of the Advisory Committee on pesticides, under art. Legislative Decree 20 March 17, 1995, # 194; Having regard to the Ministerial Decree dated September 15, 2009 implementing directive 2009/37/EC on the registration of copper compounds in annex I to the Decree Law 194/95; Having regard to the Ministerial Decree of August 31, 2009 transposing Directive 2008/125/EC on the cymoxanil as active substance in annex I to the decree 194/95; Given that Directive 91/414/EEC has been replaced by reg. (EC) No 1107/2009 and therefore the active substances concerned are now considered approved under that regulation and listed in the annex to Regulation (EU) No 540/2011; Considering that the plant protection product the company has complied with the provisions of art. 2, paragraph 2 of the aforementioned Decree transposing for both active substances concerned; Considering also that the product will have to be reassessed in accordance with the uniform principles laid down in Regulation (EC) 1107/2009 of the European Parliament and of the Council implementing Regulation (EU) No. 546/Commission 2011 and annex VI of Decree Law 194/95, on the basis of a dossier satisfying the requirements of regulations (EC) No 544/545/2011 and 2011 and annex III of Decree Law 194/95; Considered to limit the validity of the authorization of the product in question in August 31, 2019, expiration date assigned to the reference product, subject to the formalities and adjustments in accordance with the uniform principles laid down in Regulation (EC) 1107/2009 of the European Parliament and of the Council implementing Regulation (EU) No 546/2011; Considering also that for the reference plant protection product has already been presented a dossier satisfying the requirements of Regulation (EU) no 545/2011 as well under art. Ministerial Decree of 3 August 31, 2009, within the time prescribed by the latter; Saw the deposit pursuant to Ministerial Decree on September 28, 2012 "Restatement of tariffs relating to the placing on the market of plant protection products to cover sustained performance and made a request, in the implementation of Regulation (EC) 1107/2009 of the European Parliament and the Council";
Decreta: from the date of this Decree and until August 31, 2019 the enterprise Isagro SpA with registered office in Milano, via Caldera, 21, is authorized to enter the plant protection product on the market called CYTORAM COMBI WG with the composition and conditions indicated on the label attached to this Decree. It is without prejudice to any subsequent fulfilment and adapting the conditions for authorisation of the plant protection product, in conformity to Community measures and other conditions relating to those active substances components. The product is packaged in sizes from 0.5-1 Kg-5-10-20. The product is prepared at the establishment of the company: Isagro SpA-Adria Cavanella Po (RO);
Isagro SpA-Aprilia (Latina). The above mentioned product is recorded at # 16190. Are approved as an integral part of this Decree attached labels with which the product is to be marketed. Regarding the label classified the conditions laid down in reg. 1272/2008 is equivalent to that proposed by the undertaking which owns the reference product, suitable for classification under the conditions laid down by the same reg. 1272/2008, as indicated in the communiqué of the Ministry of health of January 14, 2014. This Decree will be published in the official journal of the Italian Republic and communicated to the undertaking concerned. The abovementioned product data are available in the "database" of the area dedicated to plant protection products of the portal www.salute.gov.it.
Rome, December 9, 2014 General Manager: Rajput
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