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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 review 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 March 31, 1998 Legislative Decree 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 act November 13, 2009 # 172 on "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 on "regulation for the simplification of procedures for authorization for the production, marketing and sale of pesticides and related adjuvants", 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 the "implementation of 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 submitted on November 11, 2014 by the company Cheminova Deutschland GmbH & co. Kg, headquartered in Stader Elbstrasse, D-21683 Stade (Germany), in order to obtain the authorisation of the plant protection product containing the active substance propoxycarbazone DUO named HERMES-sodium, iodosulfuron-the antidote-sodium and agronomic herbicide safener produce methyle bromide diethyl, equal to the reference product called Miscanti duo recorded at # 14770 with D.D. on December 21, 2011, of the enterprise; Noted that technical and administrative verification of the Office has confirmed 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 and in particular that the product is equal to the quoted reference product Miscanti duo recorded at # 14770; Having regard to the Ministerial Decree of February 6, 2004 transposing Directive 2003/84/EC on sodium iodosulfuro-methyl as an active substance in annex I to the decree 194/95; Having regard to the Ministerial Decree of April 9, 2004 transposing Directive 2003/91/EC relating to the inclusion of the active substance propoxycarbazone-sodium in annex I of the legislative decree 194/95; Given that Directive 91/414/EEC has been replaced by reg. EC No 1107/2009 and therefore the active substances concerned have now approved under that regulation and listed in 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 components; Considering also that the reference product was evaluated according to the uniform principles provided for in annex VI of decree 194/95 on the basis of a dossier in accordance with annex III; Considered to limit the validity of the authorization to the January 31, 2017, due date assigned to the reference product; Saw the deposit to D.M. July 9, 1999;
Decreta: from the date of this order until January 31, 2017, the company Cheminova Deutschland GmbH & co. KG, headquartered in Stader Elbstrasse, D-21683 Stade (Germany), it is authorized to enter the plant protection product on the market called ERMES DUO 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 question and the reference, even according to Community measures and other conditions relating to those active substances and the antidote and agronomic components. The product is packaged in sizes: 1-0.33-0.66-1.5 Kg. The product is imported in bundles from the settlement of foreign companies: Cheminova Deutschland GmbH & co. KG, Stader Elbstrasse, D-21683 Stade (Germany), Bayer CropScience AG-Industrial Park Hoechst, D-65926, Frankfurt am Main (Germany). The above mentioned product is registered at no. 16216. The label attached to this Decree, by which the plant protection product must be placed on the market, it is equivalent to that proposed by the undertaking which owns the reference product, suitable for grading the conditions laid down in reg. 1272/2008, as indicated in the communiqué of the Ministry of health of January 14, 2014. This Decree will be notified, by administrative means, to the undertaking concerned and published in the official journal of the Italian Republic.
Rome, February 16, 2015 Director General: Rajput
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