Authorisation Of The Plant Protection Product ' Zetaram Tri-Flo».

Original Language Title: Autorizzazione all'immissione in commercio del prodotto fitosanitario«Zetaram Tri-Flo».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-24&atto.codiceRedazionale=15A01113&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

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 made on The undertaking Phoenix-September 19, 2014 srl with registered office in Padua, via Venezia 9/in order to obtain the authorisation of the plant protection product called TRI-FLO ZETARAM containing the active substance copper sulfate tribasic, equal to the reference product called Cutril Top recorded at # 12395 with D.D. on November 12, 2007, amended subsequently by decrees whose last on January 24, 2012, 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 and in particular that the product is equal to the quoted reference product Cutril Top recorded at # 12395;

There is a legitimate agreement between the company and the company's owner of Phoenix-reference product; 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 of the legislative decree 194/95; Given that Directive 91/414/EEC has been replaced by reg. (EC) No 1107/2009 and therefore this active substance is now considered approved in accordance with 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 to the active substance 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. Commission 546/2011 and annex VI of the legislative decree 194/95, on the basis of a dossier satisfying the requirements of regulations (EC) No 544/2011 and 545/2011 and annex III of decree 194/95; Considered to limit the validity of the authorization of the product in question in November 30, 2016, 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 the Commission; Considering also that for the reference plant protection product has already been presented a dossier satisfying the requirements of Regulation (EC) no 545/2011, and in accordance with art. 3 of the aforementioned ministerial decree dated September 15, 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 November 30, 2016, the undertaking Phoenix-The srl with registered office in Padua, via Venezia 9/A, are authorized to enter the plant protection product on the market called Zetaram Tri-Flo 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 100 ml-150-200-250-500; L 1-5-10-20. The product prepared in establishments of enterprises: Chemia SpA-Sant'Agostino (FE);
Sipcam SpA-Salerano sul Lambro (LO). The above mentioned product is recorded at # 16170. It is approved as an integral part of this Decree the attached label with which the product is to be marketed. Data relating to the above product (s) are available on the website of the Ministry of Health www.salute.gov.it, under "database".
Rome, December 9, 2014 General Manager: Rajput